PlainRecalls
FDA Devices Moderate Class II Terminated

Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station 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.

Reported: August 26, 2020 Initiated: June 18, 2020 #Z-2811-2020

Product Description

Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station 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.

Details

Units Affected
118 units
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.
Location
Andover, MA

Frequently Asked Questions

What product was recalled? ▼
Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station 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.. Recalled by Philips North America, LLC. Units affected: 118 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 26, 2020. Severity: Moderate. Recall number: Z-2811-2020.

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