Recall Z-2810-2020— Philips North America, LLC

Name: FDA recall Z-2810-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-18

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2020-06-18, terminated 2023-01-10. It names one FDA 510(k) clearance: K090785. 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 synchronization for the MRI scanner.. 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..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-06-18
Terminated: 2023-01-10
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K090785 — MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214Invivo Corp.·cleared 2009-12-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.