Philips HeartStart MRx Monitor/Defibrillators Recalled for Capacitor Degradation
Philips is recalling 1,553 HeartStart MRx Monitor/Defibrillators because automated tests may degrade capacitors and the low battery indicator may fail.
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 medical device with defects that could impact the reliability of life-saving therapy and battery status indicators, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Philips Medical Systems, Inc. is recalling 1,553 units of the HeartStart MRx Monitor/Defibrillators, models M3535A and M3536A. The recall covers units distributed worldwide, including the United States, Australia, Canada, and numerous other countries.
The recall is due to two specific defects. First, the device may perform weekly automated tests on an hourly basis, which can cause the therapy capacitors to degrade sooner than intended. Second, when the device is connected to AC or DC power and the battery is missing or has a charge level below 10%, the Ready for Use (RFU) indicator may fail to provide the expected low battery indication.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Philips Medical Systems for instructions on how to resolve these issues.
The recalled product
- Product
- Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
- Manufacturer
- Philips Medical Systems, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 1,553
Distribution
Distributed nationwide across the United States.
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