Reported Sep 28, 2016 · Terminated
HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
Philips Electronics North America Corporation
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 Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- HeartStart
- MRx Monitor/Defibrillator ModelsM3535A and M3536A
- Lot codes and dates
- US Serial Numbers
79 of 79 codes
US00100227US00100297US00100326US00100337US00100429US00100715US00101184US00101468US00101676US00101690US00102018US00203809US00205745US00205756US00206142US00206498US00206615US00206821US00207095US00207101US00207144US00207209US00207268US00207295US00207321US00207324US00207345US00208019US00208263US00208431US00208519US00210744US00210966US00211478US00211485US00212939US00213455US00213819US00214103US00214173US00214222US00316387US00316389US00316444US00317530US00318184US00318460US00321017US00321936US00323885US00325280US00326630US00327632US00328050US00328154US00328968US00330028US00330043US00330093US00331414
- US00571887 US00574441 US00574758 Canada
US00100770US00101622US00101811US00204864US00204987US00205107US00325446US00325734
- US00539650 US00565585 US00569569 ROWMRx units that have the Old Cap Plate, shipped before 2010
US00101691US00208635US00327490US00101209US00206875US00208214US00209571US00212610US00212964US00100372US00536445US00100883US00207958US00100861US00211015US00100171US00100628US00534545US00321215US00205732US00208194
- US Serial Numbers
- Amount recalled
- 394 units
Where it was sold
- Nationwide
Why it was recalled
The handle can separate from the MRx housing due to breakage of mounts on the rear case.
This product could cause temporary or reversible health problems — stop using it.
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