Reported Jul 18, 2012 · Terminated
Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the…
Philips Healthcare Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Healthcare Inc. · 3000 Minuteman Road · Andover, MA · 01810
Is this the product you have?
- 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 qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
- Lot codes and dates
- Serial Numbers
US00558452US00558453US00558493US00558494US00558539 US00558540US00558546US00558547US00558569US00558576 US00558584US00558595US00558596US00558597US00558615 US00558617US00558618US00558619US00558620US00558621 US00558625US00558626US00558627US00558628US00558629 US00558630US00558640US00558641US00558642US00558643 US00558644US00558779US00558780US00558950US00558952
- Serial Numbers
- Amount recalled
- 35 units
Where it was sold
Why it was recalled
Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG
This product could cause temporary or reversible health problems — stop using it.
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