Philips HeartStart MRx Monitor/Defibrillator Recalled for Software Issue
Philips is recalling HeartStart MRx Monitor/Defibrillators because a software issue may cause the automated Ready-For-Use test to stop in an abnormal state when the device is turned off.
What this means for you
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 used for life-critical functions (termination of ventricular tachycardia and ventricular fibrillation) where a software failure could compromise device readiness, representing a risk of harm even though no injuries have been reported.
Plain-English summary
Philips Electronics North America Corporation is recalling 81,161 units of the HeartStart MRx Monitor/Defibrillator. The affected models are M3535A and M3536A, with specific software versions F.03.06 and earlier for the M3535A, and T.00.05 and earlier for the M3536A. The devices were distributed worldwide, including the United States and Puerto Rico.
The recall is due to a software issue where the automated Ready-For-Use (RFU) test may stop in an abnormal state when the device is turned off. This issue affects devices manufactured prior to June 4, 2015, with serial numbers ranging from US00100100 to US00587045. The devices are intended for the termination of ventricular tachycardia and ventricular fibrillation.
Healthcare facilities and users should check their device models and software versions to determine if they are affected. If a device is affected, users should contact Philips for instructions on how to resolve the issue. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 81,161
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 (2)
- Devices manufactured prior to June 4
- 2015. Affected serial numbers range from US00100100 - US00587045.
Distribution
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