Siemens Medical Solutions USA, Inc

54 FDA enforcement actions

54 Total Recalls

16 Class I

38 Class II

0 Class III

Firm Details

Product Types: device
States: PA, WA

All Recalls

Class II: Risk 12/29/2025 device

Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Class II: Risk 12/29/2025 device

Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Class II: Risk 12/19/2025 device

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II: Risk 12/19/2025 device

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II: Risk 12/19/2025 device

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II: Risk 12/19/2025 device

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II: Risk 12/05/2025 device

A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.
Class II: Risk 10/24/2025 device

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Class II: Risk 10/24/2025 device

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Class II: Risk 10/24/2025 device

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Class I: Dangerous 10/01/2025 device

There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I: Dangerous 08/28/2025 device

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I: Dangerous 08/28/2025 device

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I: Dangerous 08/28/2025 device

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I: Dangerous 08/28/2025 device

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I: Dangerous 08/28/2025 device

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I: Dangerous 08/28/2025 device

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I: Dangerous 08/28/2025 device

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I: Dangerous 08/28/2025 device

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I: Dangerous 08/28/2025 device

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I: Dangerous 08/28/2025 device

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I: Dangerous 08/28/2025 device

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I: Dangerous 08/28/2025 device

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I: Dangerous 08/28/2025 device

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I: Dangerous 08/28/2025 device

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I: Dangerous 08/28/2025 device

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class II: Risk 08/12/2025 device

Limited system movements after startup .
Class II: Risk 06/04/2025 device

A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
Class II: Risk 06/04/2025 device

A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
Class II: Risk 05/15/2025 device

In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Class II: Risk 05/15/2025 device

In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Class II: Risk 05/15/2025 device

In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Class II: Risk 05/15/2025 device

In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Class II: Risk 01/02/2025 device

A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.
Class II: Risk 08/15/2024 device

If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
Class II: Risk 08/15/2024 device

If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
Class II: Risk 08/15/2024 device

If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
Class II: Risk 07/03/2024 device

If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Class II: Risk 07/03/2024 device

If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Class II: Risk 07/03/2024 device

If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Class II: Risk 07/03/2024 device

If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Class II: Risk 07/02/2024 device

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Class II: Risk 07/02/2024 device

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Class II: Risk 07/02/2024 device

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Class II: Risk 07/02/2024 device

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Class II: Risk 05/31/2024 device

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II: Risk 05/31/2024 device

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II: Risk 05/31/2024 device

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II: Risk 05/31/2024 device

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II: Risk 05/31/2024 device

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II: Risk 05/31/2024 device

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II: Risk 05/31/2024 device

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II: Risk 05/31/2024 device

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II: Risk 05/31/2024 device

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire

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.