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U.S. Department of Health and Human Services

Class 2 Device Recall GE QUASAR NUCLEAR MEDICINE SYSTEM

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 Class 2 Recall
GE QUASAR NUCLEAR MEDICINE SYSTEM
see related information
Date Posted April 10, 2009
Recall Status1 Open
Recall Number Z-1119-2009
Recall Event ID 50927
Premarket Notification
510(K) Number
K022960 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product GE Healthcare, Infinia, Model Numbers: ASM000886 ASM001391 ASM001333 ASM001465 ASM001473 ASM001620 ASM500016 H3000WM H3000WT H3000WY and SYS000041. The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
Code Information Model Number ASM000886: 16017 16004 16007 16012 16006 16008 16010 16023 16039 16026 16025 16015 16052 16022 16055 16065 16027 16142 16084 16101 16030 16054 16054 16079 16042 16064 16062 16109 16060 16100 16097 16129 16125 16130 16160 16110 16136 16151 16161 16145 16184 16173 16156 16080 16178 16126 16113 16096 16107 16170 16003 16003 16059 17049 17029 17061 17050 17052 17046 17029 17068 and 17154; Model Number ASM001333: 16001 16049 16043 16040 16028 16009 16051 16053 16044 16037 16015 16099 16035 16048 16020 16053 16013 16026 16036 and 16014; Model Number ASM001391: 16063 16076 16073 16102 16106 16088 16075 16122 16124 16074 16120 16083 16149 16152 16056 16150 16153 16105 16162 16182 16163 16166 16188 16132 16058 16167 16131 16216 16168 16217 16221 16179 16164 16094 16169 16187 16090 16172 16177 16175 16093 16183 16186 16091 16246 16238 16041 16174 16104 16050 16073 16140 16078 16139 16158 and 16067; Model Number ASM001465: 16195 16192 16205 16205 16198 16212 16219 16210 16206 16193 16227 16270 16273 16203 16267 16281 16288 16200 16313 16342 16294 16330 16286 16303 16327 16299 16332 16243 16252 16333 16290 16364 16360 16339 16335 16344 16245 16381 16385 16176 16377 16362 16366 16388 16320 16334 16399 16384 16380 16412 16413 16411 16236 16369 16432 16428 16289 16404 16405 16408 16256 16414 16429 16365 16427 16433 16394 16343 16230 16441 16426 16443 16435 16439 16470 16471 16391 16223 16466 16475 16376 16464 16455 16511 16349 16510 16514 16515 16500 16532 16451 16538 16493 16533 16537 16547 16487 16395 16482 16505 16528 16517 16549 16560 16529 16508 16508 16520 16564 16445 16445 16438 16476 16278 16378 16347 16211 16415 and 16421; Model Number ASM001473: 16254 16276 16316 16314 16308 16283 16323 16298 16326 16284 16280 16262 16345 16331 16291 16337 16312 16352 16371 16346 16355 16368 16315 16356 16266 16379 16410 16398 16321 16416 16293 16340 16374 16429 16318 16406 16420 16319 16456 16440 16450 16449 16477 16460 16329 16302 16492 16474 16448 16499 16498 16490 16478 16430 16494 16496 16309 16400 16491 16452 16419 16328 16397 16462 16191 16418 and 16495; Model Number ASM001620: 16581 16574 16592 16645 16632 16622 16611 16661 16668 16595 16625 16587 16656 16708 16629 16638 16566 16663 16617 16694 16721 16692 16673 16742 16702 16738 16675 16745 16725 16715 16719 16688 16613 16726 16704 16714 16777 16674 16776 16805 16645 16770 16782 16759 16791 16837 16798 16836 16830 16842 16766 16853 16616 16577 16847 16835 16857 16851 16860 16824 16858 16834 16653 16818 16894 16752 16736 16883 16655 16870 16875 16896 16594 16902 16801 16868 16881 16909 16943 16897 16941 16939 16942 16819 16867 16810 16877 16940 16890 16839 16980 16668 16989 16740 16717 16956 16997 17083 16923 17022 16996 16705 17039 and 16695; Model Number ASM500016: 16501 16522 16534 16535 16576 16575 16553 16516 16506 16562 16557 16542 16541 16551 16602 16573 16614 16583 16586 16571 16607 16569 16578 16621 16649 16635 16669 16593 16639 16647 16681 16660 16580 16684 16679 16677 16686 16646 16657 16667 16637 16693 16699 16689 16665 16654 16676 16666 16697 16718 16610 16701 16563 16716 16579 16424 16710 16698 16707 16733 16747 16584 16584 16706 16709 16765 16239 16605 16725 16741 16768 16749 16751 16779 16746 16750 16792 16792 16773 16536 16780 16790 16769 16600 16797 16814 16817 16807 16802 16601 16690 17030 and 16815; Model Number H3000WM: 16353; Model Number H3000WT: 16115 16207 16224 16229 16220 16208 16235 16244 16234 16250 16279 16295 16269 16301 16285 16293 16324 16255 16271 16370 16233 16372 16422 16442 16382 16437 16453 16425 16457 16454 16465 16259 16469 16509 16519 16497 16527 16479 16479 16531 16524 16434 16489 16567 16539 16502 16446 16311 16627 16640 16608 16636 16641 16634 16540 16659 16628 16643 16658 16209 16228 16685 16626 16513 16548 16664 16672 16559 16670 16662 16720 16696 16734 16713 16763 16735 16748 16761 16767 16775 16803 16762 16536 16783 16812 16310 16392 16731 16788 16728 16723 16214 16504 16799 16502 16249 16503 16756 16760 16680 16376 16518 16612 16525 16300 16297 16447 16732 16786 16710 16758 16786 16731 16213 16808 16804 16135 16848 16800 16833 16816 16806 16789 16822 16841 16840 16839 16829 16832 16437 16587 16866 16861 16863 16825 16900 16916 16872 16882 16908 16917 16772 16929 16935 16920 16778 16959 16964 16196 16263 16305 16913 16526 16648 16796 16991 16912 17003 17031 17006 17056 17012 16971 16983 16851 17009 17027 17073 17014 17014 17074 17064 17043 17117 17080 17155 17059 17142 17160 17152 17123 16296 16904 17146 17212 17177 17216 17218 17015 17223 16993 16218 17184 17234 17246 17275 17282 17274 17257 17279 17291 17134 17270 17196 17308 17302 17230 16984 17261 17334 17355 17315 17242 17168 17283 16973 17378 17371 17380 17393 17409 17396 17292 17221 17186 and 16483; Model Number H3000WY: 16282 16204 16423 16143 16423 and 17085; and Model Number SYS000041: 16005 16034 16018 16045 16092 16016 16123 16098 16072 16084 16111 16136 16108 16155 16116 16180 16189 16185 and 16137.
Recalling Firm/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
The metal pin in the adjustable head holder, which is used to acquire Brain SPECT data on Infinia systems (Infinia, Infinia Hawkeye¿, and Infinia Hawkeye¿ 4), creates an artifact on the patient's cerebellum, which may lead to the potential for misdiagnosis.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action Consignees were sent a GE "Product Safety Notification" letter dated April 2008. The letter was addressed to Hospital Administrators, and Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. Contact your local sales or service representative for further information regarding this notification by calling 1-800-437-1171 (within the US or Canada) and 1-262-896-2890 (outside the US).
Quantity in Commerce 365 US and 408 OUS
Distribution Worldwide Distribution -- USA (DC and Puerto Rico) including states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, and WI and countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech, Denmark, Ecuador, Egypt, Finland, Finland, Egypt, Finland, France, Germany, Greece, Hungry, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Republic of Georgia, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom.
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.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA
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