Z-2810-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2020
- Initiation Date
- June 18, 2020
- Termination Date
- January 10, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,545 Units
Product Description
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.
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 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.
Code Information
Product #: 989803191341 Manufacturing date codes 2018-12-DD to 2020-02-DD