Devices

Device Recall Philips HeartStarMRtX

Model / Serial
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
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Nationwide Canada Australia, Brazil , China, France, Germany, Great Britain, Hong Kong, Indonesia, Italy,Latvia, New Zealand,Saudi Arabia, and South Africa
Product Description
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.
Manufacturer
Philips Medical Systems
1 Event
- Recall of Device Recall Philips HeartStarMRtX

Manufacturer

Philips Medical Systems

Manufacturer Address
Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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