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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare HeartStart MRx

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  Class 2 Device Recall Philips Healthcare HeartStart MRx see related information
Date Initiated by Firm August 26, 2016
Create Date September 19, 2016
Recall Status1 Terminated 3 on July 24, 2020
Recall Number Z-2842-2016
Recall Event ID 75041
510(K)Number K031187  K040404  K051134  K061707  K062233  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product HeartStart MRx Monitor/Defibrillator
Models: M3535A and M3536A
Code Information 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.
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
978-659-3000
Manufacturer Reason
for Recall		 The handle can separate from the MRx housing due to breakage of mounts on the rear case.
FDA Determined
Cause 2		 Device Design
Action Philips Healthcare issued customer an Urgent Medical Device Correction notification/Field Safety Notice on 11/19/14. The Urgent Medical Device Correction notification/Field Safety Notice FSN86100158A informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer, and identifies what action Philips plans to take to remedy the issue. You can continue to use your MRx prior to receiving the hardware upgrade. If one or both sides of the handle are found to have separated from the MRx housing, continue to treat your patient per existing protocols. Do not use the handle to carry the MRx. The MRx can be carried in another manner. For example, the MRx shoulder strap or bed rail hook can be used if available on the unit A hardware upgrade will be provided free of charge for all units affected by one or more of these issues. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade. Contact your local Philips representative or call 1-800-722-9377.
Quantity in Commerce 394 units
Distribution Worldwide distribution. US Nationwide, Canada, AUSTRALIA, FRANCE, GERMANY, INDIA, JAPAN, NETHERLANDS, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, and UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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