FDA-Device2020-08-26Class II
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.
Philips North America, LLC
Hazard
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.
Sold states
World wide distribution. Firm reports distributing more product then quantity manufactured. Clarification requested. And received. Firm made error in counting number of batteries distributed.
Affected count
24,545 Units
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2810-2020Don't want to check this manually?
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