IntelliVue Patient Monitor MX500 recall
IntelliVue Patient Monitor MX500. Model Number: 866064
Why was IntelliVue Patient Monitor MX500 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- IntelliVue Patient Monitor MX500. Model Number: 866064
- Recalling firm
- Philips North America Llc
- Quantity
- 45 units
- Distribution
- US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
- Recall date
- February 12, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)