Philips HeartStart MRx Defibrillator Batteries Recalled for Shutdown Risk
Philips is recalling 43,792 HeartStart MRx defibrillator batteries because they may shut down unexpectedly when exposed to high electromagnetic interference.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (defibrillator) where a failure (unexpected shutdown) could prevent life-saving treatment, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips Medical Systems, Inc. is recalling 43,792 HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries, Revision J. The recall involves specific serial numbers and a defined range of serial numbers, as detailed in the official notice.
The batteries are being recalled because the HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy sources. This device is intended for use by qualified medical personnel for the termination of ventricular tachycardia and ventricular fibrillation.
The affected batteries were distributed worldwide, including nationwide in the United States and in numerous international countries. Users should check their device serial numbers against the recall list and contact Philips Medical Systems for further instructions on replacement or repair.
The recalled product
- Product
- HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device…
- Manufacturer
- Philips Medical Systems, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 43,792
Distribution
Distributed nationwide across the United States.
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