Philips North America Llc

138 FDA enforcement actions

138 Total Recalls

3 Class I

135 Class II

0 Class III

Firm Details

Product Types: device
States: MA

All Recalls

Class II: Risk 12/12/2025 device

It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025 device

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/29/2025 device

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
Class II: Risk 10/29/2025 device

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
Class II: Risk 08/13/2025 device

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II: Risk 08/13/2025 device

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II: Risk 08/13/2025 device

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II: Risk 08/13/2025 device

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II: Risk 08/13/2025 device

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II: Risk 08/13/2025 device

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II: Risk 08/13/2025 device

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II: Risk 08/13/2025 device

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II: Risk 08/13/2025 device

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II: Risk 08/13/2025 device

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II: Risk 05/29/2025 device

Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 05/13/2025 device

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II: Risk 04/07/2025 device

Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
Class II: Risk 04/01/2025 device

Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
Class II: Risk 03/10/2025 device

Potential for collimator to fall as a result of incorrect installation.
Class II: Risk 03/10/2025 device

Potential for collimator to fall as a result of incorrect installation.
Class II: Risk 02/25/2025 device

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Class II: Risk 02/25/2025 device

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Class II: Risk 02/25/2025 device

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Class II: Risk 01/15/2025 device

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Class II: Risk 01/15/2025 device

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Class II: Risk 01/15/2025 device

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Class II: Risk 01/15/2025 device

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Class II: Risk 01/15/2025 device

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Class II: Risk 11/20/2024 device

The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potentially causing the client device to appear to drop out from the network. 2. if the Access Point experiences a disconnection from the Access Point Controller exceeding 4 minutes, the Access Point may not transition through the desired state to all for clean reconnection of the client radio link. 3. Potential to experience higher than expected data dropouts, device disassociations/reassociations for their wireless clients, and frequent "Loss of AP" alerts. 4. Potential for the Smart-hopping Access Point is affected by a software issue where the Access Point will resent after 82.85 days when the frame counter reaches its limit. This causes the latest synchronization check to fail and potential for loss of patient data.
Class II: Risk 11/16/2024 device

Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.
Class II: Risk 11/04/2024 device

Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II: Risk 11/04/2024 device

Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II: Risk 11/04/2024 device

Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II: Risk 11/04/2024 device

Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II: Risk 11/04/2024 device

Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II: Risk 11/04/2024 device

Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II: Risk 11/04/2024 device

Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II: Risk 11/04/2024 device

Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II: Risk 11/04/2024 device

Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II: Risk 11/04/2024 device

Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II: Risk 11/04/2024 device

Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II: Risk 11/04/2024 device

Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II: Risk 11/04/2024 device

Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II: Risk 09/03/2024 device

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Class II: Risk 09/03/2024 device

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Class II: Risk 09/03/2024 device

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Class II: Risk 09/03/2024 device

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Class II: Risk 09/03/2024 device

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Class II: Risk 09/03/2024 device

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Class II: Risk 09/03/2024 device

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Class II: Risk 09/03/2024 device

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Class II: Risk 09/03/2024 device

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Class II: Risk 09/03/2024 device

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Class II: Risk 09/03/2024 device

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Class II: Risk 09/03/2024 device

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Class II: Risk 09/03/2024 device

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Class II: Risk 06/28/2024 device

Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
Class II: Risk 06/28/2024 device

Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
Class II: Risk 06/28/2024 device

Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
Class II: Risk 06/28/2024 device

Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
Class I: Dangerous 06/05/2024 device

Potential for coils to heat up and harm patients (burn).
Class I: Dangerous 06/05/2024 device

Potential for coils to heat up and harm patients (burn).
Class I: Dangerous 06/05/2024 device

Potential for coils to heat up and harm patients (burn).
Class II: Risk 05/22/2024 device

Potential for inaccurate fetal heart rate measurements when monitoring multiples.
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 05/03/2024 device

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Class II: Risk 04/22/2024 device

Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
Class II: Risk 04/22/2024 device

Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
Class II: Risk 04/19/2024 device

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.