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 synchronization for the MRI scanner.
This recall has been terminated (originally issued June 18, 2020).
- Company
- Philips North America, Llc
- Recall Initiated
- June 18, 2020
- Terminated
- January 10, 2023
- Recall Number
- Z-2810-2020
- Quantity
- 24,545 Units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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 #: 989803191341 Manufacturing date codes 2018-12-DD to 2020-02-DD
Root Cause
Nonconforming Material/Component
Action Taken
Philips Healthcare sent a customer notification letter dated June 2020 explaining the potential issues observed with their products. This letter instructs the consumer to contact the company with any reports of issues associated with this failure.