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U.S. Department of Health and Human Services

Class 2 Device Recall Philips HeartStart MRx Monitor/Defibrillators

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  Class 2 Device Recall Philips HeartStart MRx Monitor/Defibrillators see related information
Date Initiated by Firm April 27, 2020
Create Date May 28, 2020
Recall Status1 Terminated 3 on July 19, 2021
Recall Number Z-2157-2020
Recall Event ID 85588
510(K)Number K051134  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product Philips HeartStart MRx Monitor/Defibrillators
Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
Code Information Serial Numbers: US00100834 US00568320 US00101892 US00102393 US00206641 US00330166 US00207698 US00101198 US00602579 US00002011 US00101199 US00102000 US00102001 US00206119 US00206643 US00206812 US00206843 US00207050 US00210171 US00210937 US00210939 US00211096 US00211098 US00212132 US00212133 US00212134 US00213504 US00213507 US00317103 US00322662 US00327284 US00327290 US00327294 US00327796 US00327799 US00500001 US00534511 US00534512 US00534513 US00534514 US00535445 US00536360 US00536361 US00539849 US00539850 US00539851 US00539852 US00540841 US00545611 US00546914 US00546915 US00549033 US00549394 US00549396 US00549397 US00550766 US00550767 US00550768 US00550769 US00550770 US00550771 US00550966 US00551296 US00552735 US00553511 US00553520 US00553909 US00556154 US00556155 US00556380 US00556381 US00556382 US00556384 US00556385 US00556386 US00556388 US00556389 US00556390 US00556391 US00556392 US00556393 US00556394 US00561199 US00561200 US00565044 US00565045 US00565046 US00565047 US00565048 US00565049 US00565050 US00565051 US00565052 US00565053 US00565054 US00565055 US00565056 US00565057 US00565058 US00565779 US00565780 US00565781 US00565782 US00565783 US00565784 US00565785 US00565786 US00565787 US00565788 US00565789 US00565790 US00565791 US00565793 US00565794 US00565795 US00565796 US00565798 US00565870 US00565944 US00566589 US00566711 US00568428 US00568429 US00568430 US00569909 US00569910 US00570053 US00570054 US00570745 US00570746 US00570747 US00570748 US00570749 US00570750 US00570751 US00570752 US00573083 US00573979 US00573980 US00574104 US00574105 US00574106 US00574107 US00574109 US00574110 US00574111 US00574113 US00574114 US00574115 US00574116 US00574117 US00574118 US00574409 US00576870 US00576871 US00576872 US00576873 US00576876 US00576877 US00578292 US00578293 US00578294 US00578295 US00578296 US00578353 US00578354 US00578356 US00578357 US00578359 US00578360 US00578361 US00578363 US00578364 US00578365 US00578366 US00578367 US00578369 US00578370 US00578371 US00578373 US00578374 US00578375 US00578376 US00578434 US00578435 US00584751 US00584753 US00587193 US00587195 US00587196 US00587197 US00587198 US00587199 US00587200 US00587201 US00587202 US00587203 US00587204 US00590219 US00590220 US00590221 US00590222 US00590373 US00590374 US00590375 US00590376 US00590377 US00590378 US00593816 US00598827 US00598829 US00598830 US00598869 US00598873 US00598909 US00598910 US00598913 US00598918 US00598919 US00598920 US00599463 US00599464 US00599465 US00599466 US00599467 US00599469 US00599470 US00599471 US00601560 US00602567 US00602570 US00602571 US00602572 US00602573 US00602574 US00602575 US00602576 US00602578 US00325128 US00212396 US00212058 US00209243 US00208771 US00208773 US00316349 US00549331 US00587713 US00587712 US00539899 US00537443 US00538885 US00320747 US00320726 US00205340 US00205338 US00205339 US00540631 US00101290  US00322671 US00535712 
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Philips Customer Services
800-722-9377
Manufacturer Reason
for Recall		 HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
FDA Determined
Cause 2		 Process change control
Action Philips Issued Urgent Medical Device Removal Letter (FSN86100214) on 4/27/20 via Certified Mail to U.S. customers, via certified mail. Philips Markets Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk, action to take: Upon receipt of this notification, promptly locate the affected MRx M3535A, M3536A, and M3536M devices remove them from clinical use immediately. A Philips representative will contact you to arrange removal of the affected devices for evaluation. If you need further information or support concerning this notification. please contact your local Philips representative or call us at 1 -800-722-9377.
Quantity in Commerce 260 units
Distribution Worldwide distribution - US Nationwide distribution and the countries of China, Republic of Korea, Netherlands, Norway, 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
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