FDA Medical devices recall ·
IntelliVue Patient Monitor MX500. Model Number: 866064 recall
- Recall number
- Z-1109-2025
- Date
- (initiated January 15, 2025)
- Company / brand
- Philips North America Llc
222 Jacobs St, Cambridge, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 45 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
IntelliVue Patient Monitor MX500. Model Number: 866064
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 866064. UDI-DI: (01)00884838038776(21); Serial Numbers: DE7580A1R5, DE7580A1R4, DE7580A1R1, DE7580A1R0, DE7580A1PM, DE7580A1PL, DE7580A1PK, DE7580A1PJ, DE7580A1P5, DE351C8913, DE351C8912, DE351C8908, DE351C8911, DE351C8910, DE351C8909, DE32300881, DE32300882, DE32300883, DE32300937, DE32300936, DE32301099, DE35114607, DE35114606, DE671T0786, DE671K1669, DE671V9213, DE35133301, DE671N0625, DE671E0967, DE671E0964, DE671E0965, DE671E0968, DE671E0978, DE671E1009, DE671E1008, DE671E1007, DE671E1006, DE671E1005, DE671E1004, DE671E0977, DE671E1003, DE671E0979, DE671E1015, DE671E0966, DE671E1059.
Distribution
US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
States: Florida North Carolina
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1109-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.