Philips North America Llc: Device Recall
Recall #Z-1110-2025 · 01/15/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1110-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Philips North America Llc
- Status
- Ongoing
- Date Initiated
- 01/15/2025
- Location
- Cambridge, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74 units
Reason for Recall
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.
Product Description
IntelliVue Patient Monitor MX550. Model Number: 866066
Distribution Pattern
US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
Other Recalls by Philips North America Llc
- Class II: Risk 12/12/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
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.