Philips HeartStart MRx Defibrillator Recalled for ECG Analysis Failure
Philips is recalling 35 HeartStart MRx defibrillators because they cannot analyze ECG reports during 12-lead acquisition.
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 high-risk medical device (defibrillator) with a functional defect that could impact patient care, but no injuries or illnesses are reported in the source text, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Philips Healthcare Inc. is recalling 35 units of the HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03. The recall is due to a software defect where the device cannot analyze an ECG report during the acquisition of a 12-lead ECG.
The affected devices are intended for use by qualified medical personnel to terminate ventricular tachycardia and ventricular fibrillation. The recall covers units distributed in the United States (including Florida, Indiana, Massachusetts, New York, Ohio, Tennessee, Texas, and Virginia) and internationally to Australia, Hong Kong, and India.
No specific corrective action or consumer instructions are provided in the source text. Medical facilities should identify affected units by checking the serial numbers listed in the official recall notice.
The recalled product
- Product
- Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and…
- Manufacturer
- Philips Healthcare Inc.
- Affected units
- 35
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 (20)
- Serial Numbers: US00558452
- US00558453
- US00558493
- US00558494
- US00558539 US00558540
- US00558546
- US00558547
- US00558569
- US00558576 US00558584
- US00558595
- US00558596
- US00558597
- US00558615 US00558617
- US00558618
- US00558619
- US00558620
- US00558621 US00558625
- US00558626
- US00558627
- US00558628
Distribution
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