Device Recall Philips

Serial Numbers: 3899, 4334, 4103, 6240, 4560, 4193

Radiology Devices

2

No

Nationwide; Units were distributed to hospitals, radiologists, and health care clinics in IA, LA, ND, PA, and TX, and Washington DC.

Philips Collimators, Model numbers: 9896 010 00614, 9896 010 00615, 9804 607 00301, and 9804 602 83501. Product is a Collimator/ Beam Limiting Device and are replacement components for the Bucky Diagnost TH X-ray system.

Software versions: J.00.23 and J.00.24 (You can determine the application software release as follows: 1-Enter Service Mode through "All Controls" , "Service" 2-Under the "Other Services " menu item, click "Software Versions" 3-"Application" lists the application software version.

Cardiovascular Devices

2

No

Worldwide Distribution: USA including states of NJ, NY, OK, MI, and UT and Foreign: Australia, Finland, France, Netherlands, and the UK

Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station || Models: M3145, M3150, M3154, M3155, M3169

Serial Numbers: 4711A00132 4725A02724 4711A00354 4725A02791 4716A00562 4725A02897 4717A00702 4725A02927 4717A00703 4725A03255 4717A00705 4732A03719 4717A00706 4732A03725 4717A00724 4732A03764 4717A00725 4732A03765 4717A00799 4732A03766 4717A00857 4732A04028 4718A00957 4732A04031 4718A01077 4732A04134 4718A01078 4732A04178 4718A01120 4732A04400 4718A01121 4732A04623 4718A01454 4732A04671 4721A01670 4732A04675 4721A01711 4732A04746 4721A01731 4732A04868 4721A01773 4732A04869 4721A01797 4732A04870 4721A01828 4732A04871 4721A01919 4732A04872 4721A01993 4732A04873 4721A01994 4732A04874 4721A01997 4732A04875 4721A02164 4732A04876 4725A02354 4732A04877 4732A04890 4732A04896

Cardiovascular Devices

2

No

Worldwide Distribution -USA including states of CA, MA, TX, IN, MI, FL, MN, NC, MS, HI, RI, NH, and PA, and countries of Canada, Australia, Belgium, France, Germany, Ireland, Italy, Japan, Switzerland, United Arab Emirates, and The United Kingdom.

Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Manufactured and Distributed by; Philips Medical Systems, Andover, MA 01810

Sysco Software Version 2, release 4.1.1

Radiology Devices

2

No

USA Distribution - CO, MN, NC, NJ and TX.

MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems, || Bothell, WA, 98021

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

Cardiovascular Devices

3

No

Nationwide Canada Australia, Brazil , China, France, Germany, Great Britain, Hong Kong, Indonesia, Italy,Latvia, New Zealand,Saudi Arabia, and South Africa

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.