Philips HeartStart MRx Monitor/Defibrillator Recalled for Malfunction Risk
Philips is recalling HeartStart MRx monitor/defibrillators because the device may malfunction, potentially delaying or disabling therapy or delivering it inadvertently.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a life-saving medical device where malfunction could result in significant injury or death due to delayed or inadvertent therapy.
Plain-English summary
Philips Medical Systems, Inc. is recalling the HeartStart MRx Monitor/Defibrillator, including models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, and M3536M6. The recall covers 74,499 devices that were distributed worldwide and nationwide in the United States. The device is intended for use by qualified medical personnel to terminate ventricular tachycardia and ventricular fibrillation.
The recall is being issued because the device may malfunction. This malfunction could cause therapy to be delayed, disabled, or delivered inadvertently. The source text does not report any specific injuries or illnesses associated with this recall.
Healthcare facilities and users should check their device serial numbers against the provided ranges to determine if their units are affected. Affected devices should be removed from service and returned to Philips Medical Systems, Inc. for evaluation and repair or replacement.
The recalled product
- Product
- HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use…
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 74,499
Distribution
Distributed nationwide across the United States.
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