Reported Feb 14, 2018 · Terminated
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for…
Philips North America, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
MRx Defibrillator Model # M3535A & M3536AUDI 00884838000018(21)US00601969
- 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
- Serial Numbers
71 of 71 codes
US00601802US00601968US00601969US00602114US00602122US00602124US00602125US00602126US00602127US00602128US00602145US00602180US00602182US00602184US00602185US00602186US00602187US00602189US00602206US00602236US00602237US00602238US00602239US00602240US00602241US00602242US00602243US00602244US00602245US00602246US00602247US00602248US00602250US00602251US00602252US00602253US00602254US00602344US00602345US00602346US00602347US00602348US00602349US00602350US00602351US00602352US00602353US00602354US00602355US00602356US00602357US00602358US00602359US00602360US00602361US00602362US00602363US00602364US00602365US00602366
- Serial Numbers
- Amount recalled
- 71 units
Why it was recalled
Stop using this product now
Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.
Using this product could cause serious injury, illness or death — stop using it now.
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