Philips HeartStart MRx Monitor/Defibrillator Recalled for Therapy Failure Risk
Philips is recalling HeartStart MRx Monitor/Defibrillators because they may fail to deliver defibrillation therapy in Manual Defib or AED mode.
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 medical device that may fail to deliver life-saving therapy, which aligns with the 'Severe' criteria for significant injury risk or structural defects.
Plain-English summary
Philips Healthcare Inc. is recalling approximately 64,972 HeartStart MRx Monitor/Defibrillators. The affected devices are used for the termination of ventricular tachycardia and ventricular fibrillation. The recall includes product codes M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, and M3536M6, with serial numbers ranging from US00100100 to US00565942.
The recall was initiated because the device may fail to deliver defibrillation therapy in either Manual Defib or AED mode. This failure could prevent the device from providing necessary treatment for life-threatening heart rhythms.
The affected devices were distributed worldwide, including nationwide in the United States and in numerous other countries. Users should contact Philips Healthcare Inc. for further instructions on how to address this issue.
The recalled product
- Product
- HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.
- Manufacturer
- Philips Healthcare Inc.
- Affected units
- 64,972
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 (8)
- Serial numbers ranging from US00100100 to US00565942 Product Codes: M3536A
- M3536J
- M3536M
- M3536MC
- M3536M2
- M3536M4
- M3536M5
- M3536M6
Distribution
Distributed nationwide across the United States.
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