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

    • US00100227
    • US00100297
    • US00100326
    • US00100337
    • US00100429
    • US00100715
    • US00101184
    • US00101468
    • US00101676
    • US00101690
    • US00102018
    • US00203809
    • US00205745
    • US00205756
    • US00206142
    • US00206498
    • US00206615
    • US00206821
    • US00207095
    • US00207101
    • US00207144
    • US00207209
    • US00207268
    • US00207295
    • US00207321
    • US00207324
    • US00207345
    • US00208019
    • US00208263
    • US00208431
    • US00208519
    • US00210744
    • US00210966
    • US00211478
    • US00211485
    • US00212939
    • US00213455
    • US00213819
    • US00214103
    • US00214173
    • US00214222
    • US00316387
    • US00316389
    • US00316444
    • US00317530
    • US00318184
    • US00318460
    • US00321017
    • US00321936
    • US00323885
    • US00325280
    • US00326630
    • US00327632
    • US00328050
    • US00328154
    • US00328968
    • US00330028
    • US00330043
    • US00330093
    • US00331414
  • US00571887 US00574441 US00574758 Canada
    • US00100770
    • US00101622
    • US00101811
    • US00204864
    • US00204987
    • US00205107
    • US00325446
    • US00325734
  • US00539650 US00565585 US00569569 ROW
    • US00101691
    • US00208635
    • US00327490
    • US00101209
    • US00206875
    • US00208214
    • US00209571
    • US00212610
    • US00212964
    • US00100372
    • US00536445
    • US00100883
    • US00207958
    • US00100861
    • US00211015
    • US00100171
    • US00100628
    • US00534545
    • US00321215
    • US00205732
    • US00208194
    MRx units that have the Old Cap Plate, shipped before 2010
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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 24, 2020 · Data as of Sep 19, 5:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.