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[Recalled] 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 unde

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductPhillips 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 th
Brand / manufacturerPhilips North America, LLC
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2810-2020
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date18 June 2020
EAN / barcode989803191341

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Philips North America, LLC

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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