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U.S. Department of Health and Human Services

Class 2 Device Recall iLab Ultrasound Imaging System, models 120INS and 240INS

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 Class 2 Recall
iLab Ultrasound Imaging System, models 120INS and 240INS
see related information
Date Posted December 16, 2008
Recall Status1 Terminated on May 18, 2009
Recall Number Z-0338-2009
Recall Event ID 49420
Product Classification System, Imaging, Pulsed Echo, Ultrasonic - Product Code IYO
Product Boston Scientific iLab Ultrasound Imaging System, models 120INS and 240INS. Its intended use is for ultrasound examination of intravascular pathology. Manufactured by Boston Scientific Corporation, Fremont, CA.
Code Information ILAB120CART: UPN: H749ILAB120CARTD0 Serial #s: 4033 4058 4063 4098 4171 ACQUISITION PC: UPN H749ILACQPCFRU010 H749ILACQPCFRU01D0 H749ILACQPCFRU01H0 H749ILACQPCFRU01R0 H749ILACQPCFRU01Z0 H749ILACQPCFRU020 H749ILACQPCFRU02D0 H749ILACQPCFRU02H0 H749ILACQPCFRU02R0 H749ILACQPCFRU02Z0 H749ILACQPCFRU030 H749ILACQPCFRU03H0 H749ILACQPCFRU03R0 H749ILACQPCFRU03Z0 H749ILACQPCFRU040 H749ILACQPCFRU04R0 H749ILACQPCFRU04Z0 H749ILACQPCFRU050 H749ILACQPCFRU05R0 H749ILACQPCFRU05Z0 H749ILACQPCFRU060 H749ILACQPCFRU06R0 and H749ILACQPCFRU06Z0 Serial #s: 1580359 1611146 L10076 L10227 L10442 L10714. 1580642 1611147 L10081 L10233 L10443 L10717 1581015 1611152 L10083 L10239 L10444 L10739 1581022 1611153 L10086 L10243 L10456 L10761 1581024 1611192 L10093 L10255 L10464 L10766 1582415 1611195 L10095 L10257 L10471 L10774 1582418 1611200 L10099 L10269 L10511 L10776 1582871 1611416 L10109 L10284 L10531 L10782 1582881 1611422 L10113 L10292 L10541 L10785 1583625 1611423 L10115 L10309 L10543 L10807 1583628 1611424 L10120 L10311 L10555 L10809 1583629 1611429 L10122 L10314 L10556 L10838 1583634 1611430 L10125 L10318 L10562 L10840 1583635 1611434 L10129 L10320 L10565 L10855 1583636 1611702 L10130 L10332 L10579 L10863 1583637 16081315 L10131 L10336 L10582 L10867 1583638 L10000 L10132 L10345 L10588 L10873 1583641 L10002 L10139 L10357 L10589 L10878 1583643 L10006 L10162 L10362 L10593 L10900 1588611 L10010 L10164 L10365 L10597 L10909 1590153 L10016 L10166 L10369 L10603 L10920 1607244 L10018 L10168 L10371 L10611 L10946 1607292 L10021 L10169 L10375 L10617 L10953 1607482 L10024 L10170 L10377 L10619 L10963 1607721 L10026 L10177 L10382 L10620 L10970 1607723 L10028 L10178 L10399 L10624 L10981 1608316 L10033 L10179 L10407 L10627 L10991 1609451 L10055 L10180 L10419 L10632 L10999 1609454 L10057 L10186 L10422 L10648 L11022 1611078 L10070 L10188 L10430 L10665 L11035 1611080 L10071 L10195 L10434 L10679 L11036 1611081 L10072 L10196 L10436 L10680 L11040 1611085 L10074 L10198 L10439 L10691 L11052 1611144 L10075 L10207 L10440 L10710 L11060 and Model UPN Serial # IMAGE PROCESSOR H749ILIMGPCFRU010 H749ILIMGPCFRU01D0 H749ILIMGPCFRU01H0 H749ILIMGPCFRU01R0 H749ILIMGPCFRU01Z0 H749ILIMGPCFRU020 H749ILIMGPCFRU02R0 H749ILIMGPCFRU02Z0 H749ILIMGPCFRU030 H749ILIMGPCFRU03R0 and H749ILIMGPCFRU03Z0 296968 313715 321630 322849 336162 340786. 297060 313717 321631 322861 336163 340792 297061 313720 321632 327138 336253 340805 297062 314198 316790 327148 336256 340809 297063 314203 316792 327150 336257 341460 300862 314218 316801 329820 336269 342235 300865 314223 316802 329823 336343 342237 300866 315336 316803 329825 336344 342243 300868 315340 321641 329836 336349 342752 300876 315343 321642 329844 336718 342773 302076 315344 321647 329867 336720 806347299 302079 315426 321650 331555 336727 806347312 303104 315427 321651 331556 336734 806347323 303108 315434 323025 331564 336735 806347324 304636 315708 323029 331582 336795 806347327 304637 315709 323037 331590 336807 807348245 304640 315710 323039 332318 337432 807348248 305670 315714 323058 332319 337456 807348253 305675 315716 324211 332328 337480 807348257 306636 315720 324221 332339 338772 807348259 306637 315721 324225 332348 338777 807348268 306640 315723 324236 332349 338789 807348271 307244 315724 324240 332352 338808 807348273 307246 315725 324241 332356 338815 807348278 307247 316840 324243 332360 339827 807348279 307248 316847 324245 332374 339830 807348280 307252 316979 324256 332690 339831 807348281 307255 316984 325724 332699 339838 807348283 307770 316991 325740 332710 339839 807348286 307771 317220 325742 332715 339841 807348287 307772 317223 325745 332729 339842 807348288 307773 317235 325756 333368 339843 807348292 307777 317253 325775 333372 340048 807348293 307782 317662 325777 333373 340049 807348294 308093 317664 325778 333374 340053 807348296 308100 317668 327115 333375 340054 807348704 309466 321294 327122 333376 804344578 807348709 309469 321300 327133 333377 804344579 807348714 309470 321448 327136 333379 804345552 807348715 309475 321457 321652 333380 805346232 807348719 309476 321615 321656 333381 805346239 807348728 310273 321617 321662 333382 340067 807349080 310276 321622 321663 333385 340760 807349088 and 310277 321623 321664 333390 340767 310282 321625 321665 335825 340779 313712 321627 322846 336155 340781
Recalling Firm/
Manufacturer
Boston Scientific Corporation
47900 Bayside Pkwy
Fremont, California 94538-6515
Manufacturer Reason
for Recall
Computer malware: Products may be infected with a worm (computer malware) which could infect a computer network to which it may be connected.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Customer letters sent on Friday, Sept 5 via FedEx, 2008 to all customers. This letter will be followed up by a customer service visit. Package delivery will be tracked, as well as Reply Verification tracking forms.For further information, please contact firm at 508-652-5594.
Quantity in Commerce 357 units
Distribution World-wide distribution including USA and countries of Europe, Middle East, Africa, and Japan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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