Philips Module Charger Recall for MRI Patient Monitoring System
Philips is recalling Module Chargers used in the Expression MR400 MRI Patient Monitoring System because poor electrical contact prevents the lithium-polymer battery from charging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional defect (battery not charging) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
Philips North America, LLC is recalling the Module Charger (Product #: 989803191031) used in the Expression MR400 MRI Patient Monitoring System. The recall involves 9,705 units distributed worldwide. The affected units have manufacturing date codes prior to March 2020.
The recall is due to a problem with the Philips LI-Polymer rechargeable battery when used with the approved charging station and module charger. When the battery is inserted into the charger bay, the LED indicator lights solid red and the battery will not charge. This issue may result from poor electrical contact between the battery and the charger.
The Module Charger is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. Users should stop using the affected chargers and contact Philips for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Philips North America, LLC
- Affected units
- 9,705
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product #: 989803191031 Manufacturing date codes: prior to 2020-03
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Philips North America, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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