Philips North America, LLC recalls Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 M…

Recall date

June 18, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2812-2020

FDA classification

Class II

Brand / firm

Philips North America, LLC

Sold / distributed

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

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.