Reported Jul 4, 2012 · Terminated
Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: 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 monitor/defibrillators Models
M3535AM3536AM3536M4M3536M5
- and M3536M6 Product UsageThe 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
Manufactured between the dates of July 122011 through September 22011 and January 192012 through May 222012
- Serial numbers within the ranges ofUS00550047 to US00551654 and US00556357 to US00559493 respectively. There are also some additional MRx units that were repaired and may contain compromised components. These MRx unit
- serial numbers are identified below
US00210180US00210183US00210738US00211000US00213281 US00214706US00316827US00318163US00319241US00328491 US00329811US00333101US00536832US00538140US00543161 US00543825US00544081US00544214US00546107US00548046
- Amount recalled
- 2914 units
Where it was sold
- Nationwide
Why it was recalled
HeartStart MRx Unexpected Pads/Paddles ECG Failure
This product could cause temporary or reversible health problems — stop using it.
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