IntelliVue Patient Monitor MX550. Model Number: 866066
This recall is currently active, issued February 5, 2025. It was issued by Philips North America Llc.
- Company
- Philips North America Llc
- Recall Initiated
- January 15, 2025
- Posted
- February 5, 2025
- Recall Number
- Z-1110-2025
- Quantity
- 74 units
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Model Number: 866066. UDI-DI: (01)00884838038783(21); Serial Numbers: DE671E3020, DE671E2989, DE671E2988, DE671E3086, DE671E3085, DE671E3084, DE671E3097, DE671E3096, DE671E3095, DE671E3094, DE671E3093, DE671E3253, DE671E3246, DE671E3245, DE671E3244, DE671E3241, DE671E3240, DE671E3234, DE671E3235, DE671E3238, DE671E3239, DE671E3021, DE671E3236, DE671E3865, DE671E3863, DE671E3862, DE671E3861, DE671E3860, DE671E3859, DE671E3858, DE671E3857, DE671E3856, DE671E3855, DE671E3853, DE671E3852, DE671E3867, DE671E3871, DE671E3730, DE671E3729, DE671E3866, DE35186967, DE35186949, DE35186948, DE35186947, DE35186944, DE35186943, DE35186942, DE35186941, DE35186940, DE35186939, DE35186938, DE35186982, DE35186945, DE35199396, DE35199398, DE35199428, DE671E2030, DE671H1334, DE32302561, DE32302562, DE32301002, DE32301003, DE32301004, DE35114609, DE35114608, DE758Y7635, DE758Y7616, DE758Y7619, DE758Y7615, DE758Y7614, DE7580AWK6, DE7580AWK7, DE7580AWKB, DE7580AWK4.
Root Cause
Software design
Action Taken
Philips began notifying consignees on about 01/15/2025 via certified letters titled URGENT Field Safety Notice and URGENT Medical Device Correction letters. Consignees were instructed to ensure that there is no interruption of the cable connection between the Hamilton ventilator and the EC10 Module or IntelliBridge I/O board before use, provide the notification to all affected personnel and customers if the devices have been further distributed, and to complete and return the response form provided. A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will upgrade your ED245 Driver from revision A.0 to revision A.1. Distributors were instructed to return the Response Form attached your contact information, send the attached URGENT Field Safety Notice to each customer to whom you have distributed any affected device as soon as possible and no later than 5 days, together with the Reply Card, perform a good faith effort to get the Response Form by following up with the customer with a minimum of three attempts, and if possible, using multiple contact methods, inform Philips about the responses received, and implement the Technical solution established by Philips as soon as available within the timeframe communicated by Philips and confirm to Philips the implementation in all affected products. In case a product is not corrected, inform Philips on the reason why the technical solution cannot be implemented.