medical Class II Updated 2020-08-26

Philips North America, LLC recalls Phillips Module Charger, Product #: 989803191031 - Product U

Recalled Product

Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: World wide distribution. Firm reports distributing more product then quantity manufactured. Clarification requested. And received. Firm made error in counting number of batteries distributed.
Lot/Code Info: Product #: 989803191031 Manufacturing date codes: prior to 2020-03
View official government recall

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