Philips HeartStart MRx Monitor/Defibrillators Recalled for ECG Failure
Philips is recalling HeartStart MRx monitor/defibrillators because they may fail to display ECG signals, potentially delaying the treatment of cardiac arrhythmias.
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 is classified as FDA Class II and involves a risk-of-harm product (defibrillator) where the failure to display ECG signals could delay treatment of life-threatening arrhythmias, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Healthcare Inc. is recalling approximately 2,914 HeartStart MRx monitor/defibrillators (models M3535A, M3536A, M3536M4, M3536M5, and M3536M6) due to a defect that may cause the device to fail to display electrocardiogram (ECG) signals. The affected units were manufactured between July 12, 2011, and September 2, 2011, and between January 19, 2012, and May 22, 2012. The recall also includes specific repaired units identified by serial number that may contain compromised components.
The HeartStart MRx is a medical device used by qualified medical personnel to terminate ventricular tachycardia and ventricular fibrillation. The failure to display ECG signals could prevent clinicians from accurately monitoring a patient's heart rhythm, potentially delaying the delivery of necessary defibrillation therapy. The affected devices were distributed worldwide, including in the United States and numerous international markets.
Qualified medical personnel should stop using the affected devices and contact Philips Healthcare Inc. for instructions on repair or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel
- Manufacturer
- Philips Healthcare Inc.
- Affected units
- 2,914
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)
- Manufactured between the dates of July 12
- 2011 through September 2
- 2011 and January 19
- 2012 through May 22
- US00210183
- US00210738
- US00211000
- US00213281 US00214706
- US00316827
- US00318163
- US00319241
- US00328491 US00329811
- US00333101
- US00536832
- US00538140
- US00543161 US00543825
- US00544081
- US00544214
- US00546107
- US00548046
Distribution
Distributed nationwide across the United States.
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