CLASS II Device recall · Reported 26 Aug 2020 · FDA Enforcement Report

Phillips Module Charger, Product # recalled by Philips North America

Philips North America is recalling Phillips Module Charger, Product #: 989803191031. The recall was initiated on 18 Jun 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct #: 989803191031 Manufacturing date codes: prior to 2020-03

Quantity recalled9,705 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2812-2020
FDA event ID: 86025
Recalling firm: Philips North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 18 Jun 2020
FDA classified: 14 Aug 2020
Reported: 26 Aug 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

18 Jun 2020	Recall initiated by company
14 Aug 2020	Classified by FDA	+57 days
26 Aug 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger 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.

Where it was distributed

World wide distribution. Firm reports distributing more product then quantity manufactured. Clarification requested. And received. Firm made error in counting number of batteries distributed.

Questions about this recall

Is Phillips Module Charger, Product #: 989803191031 recalled?

Yes. Philips North America recalled Phillips Module Charger, Product #: 989803191031 on 18 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2812-2020.

Why was it recalled?

Which lots are affected?

Product #: 989803191031 Manufacturing date codes: prior to 2020-03

Where was it sold?

World wide distribution. Firm reports distributing more product then quantity manufactured. Clarification requested. And received. Firm made error in counting number of batteries distributed.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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