The Recall Desk
ModerateFDA (Devices)·Z-2810-2020·Announced 2020-08-26

Philips MRI Patient Monitoring System Battery Recall for Charging Failure

Philips is recalling 24,545 rechargeable Li-Polymer batteries used in the Expression MR400 MRI Patient Monitoring System. The batteries may fail to charge due to poor electrical contact.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional defect (charging failure) without reporting any injuries, illnesses, or deaths. This aligns with the 'Moderate' criteria for low-risk issues or voluntary precautionary recalls where harm has not been reported.

Plain-English summary

Philips North America, LLC is recalling 24,545 units of the 3.7V Rechargeable Li-Polymer Battery (Product #: 989803191341). These batteries are used in the Expression MR400 MRI Patient Monitoring System, which is intended to monitor vital signs for patients undergoing MRI procedures and provide synchronization signals for the MRI scanner.

The recall is due to a problem where the battery may not charge when inserted into its approved charging station and module charger. When this occurs, the LED indicator lights solid red. The issue may result from poor electrical contact between the battery and the charger.

The affected batteries have manufacturing date codes from 2018-12-DD to 2020-02-DD. The firm reported worldwide distribution. Users should contact Philips for further instructions on how to address the charging issue.

The recalled product

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 sy
Affected units
24,545

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product #: 989803191341 Manufacturing date codes 2018-12-DD to 2020-02-DD

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Philips North America, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →