Z-2810-2020Class II

Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 -

Name: Z-2810-2020 Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 -
Creator: Philips North America, LLC
Published: 2020-06-18
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-06-18 / Terminated / root cause: manufacturing process

FDA source

Philips North America, LLC began a recall of Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring... on 2020-06-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2810-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-18
Posted: 2020-08-14
Terminated: 2023-01-10
Recalling firm: Philips North America LLC
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.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 24,545 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.
Product codes and lots: Product #: 989803191341 Manufacturing date codes 2018-12-DD to 2020-02-DD

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2810-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2810-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-14
Z-2811-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-14
Z-2812-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-14

Product code MWI

K090785Class IIMRI Compatible Patient Monitoring System, Model 865214Invivo Corp. / cleared 2009-12-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)