Philips HeartStart MRx Monitor/Defibrillator Recalled for ECG Cable Wear
Philips is recalling HeartStart MRx Monitor/Defibrillators because the ECG trunk cable and connector block may wear prematurely, causing an interrupted ECG signal.
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 used to treat life-threatening cardiac arrhythmias. The hazard is an interrupted ECG signal, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Medical Systems, Inc. is recalling approximately 49,929 units of the HeartStart MRx Monitor/Defibrillator. The affected models are M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. These devices are used for the termination of ventricular tachycardia and ventricular fibrillation.
The recall is due to a potential defect where the ECG trunk cable and connector block may be susceptible to accelerated wear. This wear could result in an interrupted ECG signal. The affected units have serial numbers within the range of US00100100 through US00550668.
The devices were distributed nationwide in the United States and in numerous countries worldwide. Healthcare facilities and users should check their device serial numbers against the affected range and contact Philips Medical Systems for further instructions on corrective actions.
The recalled product
- Product
- Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia and ventricular fibrillation.
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 49,929
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 (1)
- Serial numbers within the range: US00100100 through US00550668
Distribution
Distributed nationwide across the United States.
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