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IntelliVue Patient Monitor MX550. Model Number: 866066 recallZ-1110-2025 · Philips North America Llc · initiated Jan 15, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-1110-2025
Status
Open, Classified
Initiated by the company
Jan 15, 2025
Posted by the FDA
Feb 5, 2025
Recalling firm
Philips North America Llc
Quantity
74 units
Product code
MHX
FDA submissions
K082583
Distribution
US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

Product description

IntelliVue Patient Monitor MX550. Model Number: 866066

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 96138).

Sources and updates

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