Philips North America Llc: IntelliVue Patient Monitor MX400. Model Number: 866060

Hazard

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.

Details from the source

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. Distribution: US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom. Quantity: 28 units Lot/code info: Model Number: 866060. UDI-DI Number: (01)00884838038752(21). Serial Numbers: DE35174105, DE35174084, DE35174083, DE35174082, DE35174080, DE35107369, DE35108320, DE35160410, DE671M4116, DE7770DA9W, DE35114616, DE35114618, DE671E8921, DE671E8917, DE7580AH50, DE7580AHEH, DE35123130, DE671V9297, DE671V9296, DE671V9298, DE35160989, DE35160994, DE35160988, DE35161272, DE35161273, DE35161274, DE7580B537, DE7580B52H.

UPC codes

00884838038752

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.