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 Recall Z-2810-2020 · Posted None
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Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeMWI
Date Initiated2020-06-18
Date Terminated2023-01-10
Product Quantity24,545 Units
Reason for Recall
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.
Firm Action
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.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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