—#182528

Product

Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.

FDA product code: MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K090785
Affected lot / code info: Product #: 989803191341 Manufacturing date codes 2018-12-DD to 2020-02-DD

Why it was recalled

A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Philips Healthcare sent a customer notification letter dated June 2020 explaining the potential issues observed with their products. This letter instructs the consumer to contact the company with any reports of issues associated with this failure.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: World wide distribution. Firm reports distributing more product then quantity manufactured. Clarification requested. And received. Firm made error in counting number of batteries distributed.

Timeline

Recall initiated: 2020-06-18
Terminated: 2023-01-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182528. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.