HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
Class I - DangerousWhat Should You Do?
- Check if you have this product: US Serial Numbers: 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 US00332111 US00534036 US00534522 US00535148 US00535803 US00539517 US00540460 US00541251 US00541256 US00541257 US00541366 US00541627 US00543683 US00543856 US00544956 US00545221 US00545649 US00554157 US00555242 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips Electronics North America Corporation
- Reason for Recall:
- The handle can separate from the MRx housing due to breakage of mounts on the rear case.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
Product Codes/Lot Numbers:
US Serial Numbers: 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 US00332111 US00534036 US00534522 US00535148 US00535803 US00539517 US00540460 US00541251 US00541256 US00541257 US00541366 US00541627 US00543683 US00543856 US00544956 US00545221 US00545649 US00554157 US00555242 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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2842-2016
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Philips Electronics North America
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