Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-2812-2020

June 18, 2020

Class II

Product summary

Firm
Philips North America, LLC
Event
Event 86025
Status
Terminated
Classification
Class II
Quantity
9,705 units
Official record key
device-enforcement:Z-2812-2020

Official wording

Reason: 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.

Code information: Product #: 989803191031 Manufacturing date codes: prior to 2020-03

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.