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U.S. Department of Health and Human Services

Class 2 Device Recall Philips HeartStarMRtX

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  Class 2 Device Recall Philips HeartStarMRtX see related information
Date Initiated by Firm July 14, 2008
Date Posted September 25, 2008
Recall Status1 Terminated 3 on March 14, 2017
Recall Number Z-2337-2008
Recall Event ID 48975
510(K)Number K031187  
Product Classification Defibrillator - Product Code MKJ
Product HeartStarMRtX Defibrillator/Monitor
Models: M3535A/M3536A
HeartStart MRx with a native 256Mbyte internal memory
card with date code "0308. The product is used for the termination of ventricular tachycardia and ventricular fibrillation.
Code Information Serial Nimbers: US00100694- US00100695 US00101003 US00101148 US00101277 US00101427 US00101443 US00101696 US00101876 US00102033 US00102552 US00102602 US00202756 US00202955 US00203505 US00203923 US00204295 US00204347 US00204361 US00204423 US00204438 US00204490 US00204648 US00205100 US00205625 US00205636 US00205650- US00205651 US00205660 US00205666 US00205688 US00205751 US00205839 US00205994 US00206144 US00206531 US00206641 US00207021 US00207313 US00207485 US00207604 US00207924 US00207930 US00208087 US00208140 US00208752 US00208789- US00208790 US00209355 US00209715 US00210183 US00210304 US00210783 US00210982 US00212242 US00212790 US00315280 US00315447 US00315464 US00316930 US00318057 US00318523 US00318538 US00319936 US00321428 US00324554 US00324581- US00324584 US00324586 US00324614- US00324616 US00324619- US00324620 US00324622 US00324624- US00324625 US00324627 US00324642 US00324645- US00324646 US00324659 US00324680 US00324707 US00324712- US00324713 US00324718 US00324720 US00324727- US00324731 US00324734 US00324736 US00324744 US00324748- US00324749 US00324751 US00324754 US00324756 US00324758- US00324761 US00324763- US00324765 US00324767- US00324769 US00324771 US00324773 US00324775 US00324777 US00324779- US00324786 US00324788- US00324789 US00324802- US00324838 US00324841- US00324845 US00324847- US00324856 US00324858- US00324929 US00324932- US00324942 US00324944 US00324947- US00324952 US00324954 US00324956- US00324959 US00324961- US00324968 US00324970- US00324971 US00324973- US00324975 US00324979- US00324980 US00324982 US00324984 US00324986 US00324997 US00325003 US00325005 US00325007- US00325008 US00325010 US00325023- US00325024 US00325028 US00325031- US00325032 US00325035 US00325038 US00325040- US00325043 US00325045 US00325048- US00325049 US00325054- US00325057 US00325062- US00325064 US00325066 US00325068- US00325069 US00325081- US00325082 US00325085- US00325087 US00325094- US00325096 US00325166 US00325231 US00325234- US00325235 US00325583- US00325587 US00325612- US00325613 US00325616 US00325621 US00325623- US00325624 US00325628 US00325651 US00325654- US00325655 US00325661- US00325664 US00325674- US00325690 US00325692 US00325694 US00325696- US00325701 US00325703- US00325726 US00325728- US00325731 US00325734- US00325742 US00325744- US00325746 US00325748- US00325755 US00325757- US00325759 US00325762- US00325763 US00325766- US00325768 US00325770- US00325771 US00325773- US00325775 US00325780- US00325781 US00325787- US00325790 US00325795- US00325797 US00325799- US00325800 US00325804 US00325806- US00325808 US00325810 US00325812- US00325814 US00325816- US00325823 US00325827- US00325828 US00325830- US00325838 US00325847- US00325848 US00325851- US00325853 US00325856 US00325858- US00325859 US00325861 US00325863 US00325867 US00325870- US00325871 US00325873- US00325875 US00325877- US00325878 US00325889 US00325903 US00325908- US00325909 US00325943 US00325957 US00325979 US00325994 US00326002 US00326008 US00326034 US00326043 US00326058 US00326061- US00326065 US00326069 US00326073- US00326075 US00326079 US00326084 US00326225 US00326248 US00326350 and US00326505 
Recalling Firm/
Manufacturer		 Philips Medical Systems
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact SAME
978-687-1501
Manufacturer Reason
for Recall		 Defective internal memory cards may exhibit one or more of the following behaviors: "Device repeatedly restarts approximately every 20 seconds "Slow device start-up of approximately 15 seconds or more. During this time, the MRx displays either a blank screen or the Philips HeartStart MRx Start-up screen prior to displaying the selected mode of operation (i.e. Monitor, AED, Pacing or Manual Defib mode). "Internal Memory Failure INOP message when attempting to print an event from the Data Management screen. "When printing from the Data Management screen, a patients Event Summary prints with some clinical events missing.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Philips issued an Urgent Medical Device Correction notification on July 17, 2008. Customers in the US received their communication package via UPS. Letters to international customers mailed via a tracked method by local Philips representatives. Customers were informed on how to locate the serial number on their devices to determine whether or not they have affected units in their inventory. Customers are asked to follow the "Action To Be Taken By Customer/User" while they await , their correction. If users continue to use prior to correction, a back up defibrillator should be readily available. Devices that exhibit repeated restart or slow start -up should be removed from service. The correction will come in the form of an internal memory card replacement. Philips will contact customers to arrange for the correction of their devices. Contact Philips Medical at 1-978-687-1501 for assistance.
Quantity in Commerce 523 units
Distribution Nationwide Canada Australia, Brazil , China, France, Germany, Great Britain, Hong Kong, Indonesia, Italy,Latvia, New Zealand,Saudi Arabia, and South Africa
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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