Device Recall GE QUASAR NUCLEAR MEDICINE SYSTEM

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.

Radiology Devices

2

No

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.

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.

Model Number H3000WR: 16306 and 16275;   Model Number H3000WW: 16086 16202 16231 16241 16268 16265 16247 16277 16201 16272 16274 16258 16278 16242 16257 16341 16307 16232 16351 16358 16363 16383 16134 16383 16367 16095 16359 16338 16338 16390 16407 16253 16463 16242 16461 16484 16467 16472 16486 16393 16488 16507 16545 16459 16546 16523 16550 16521 16402 16417 16599 16556 16480 16558 16597 16555 16590 16603 16598 16606 16618 16630 16596 16530 16619 16609 16631 16623 16691 16708 16620 16633 16642 16599 16703 16591 16671 16764 16757 16604 16787 16615 16287 16690 16568 16458 16711 16727 16386 16729 16444 16260 16678 16687 16588 16700 16653 16730 16782 16824 16342 16879 16003 16801 16884 16292 16906 16892 16931 16952 16954 16954 16222 16936 16895 16257 16951 16373 16958 16389 16982 16981 17038 16754 16985 16998 16855 16458 16644 and 16544;   Model Number H3000WZ: 16237 16350 16251 16375 16387 16512 16565 16582 16403 16240 16183 16572 16485 16552 16248 16215 16261 16197 16468 16361 16624 16813 16409 16831 16481 16240 16264 16891 16961 16826 and 17148;   Model Number H3000YM: 16046 16011 16021 16057 16027 16128 16077 16097 16019 16103 16082 16112 16029 16121 16157 16148 16159 16038 16147 16146 16127 16154 16174 16024 16024 and 16133; and   Model Number H3000YS: 16068 16089 16141 16085 and 16061.

Radiology Devices

2

No

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.

GE Healthcare, Hawkeye¿ for Infinia, Model Numbers: H3000WR , H3000WW, H3000WZ , H3000YM and H3000YS. || 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.

Model Number 5178728: 17445 17001 17035 17023 17008 16988 17007 17010 17063 17077 17053 16995 17088 17098 17090 16990 17054 17099 17081 17060 17128 17140 17116 17004 17089 17036 17045 17129 17130 17108 17093 17171 17144 17158 17069 17135 17040 17172 17132 17183 17153 17201 17182 17111 17190 17187 17175 17169 17169 17169 17133 17213 17166 17104 17203 17141 17204 17139 17113 17224 17226 17228 17210 17229 17119 17255 17239 17233 17002 17266 17245 17276 17264 17248 17094 17256 17273 17254 17281 17294 17305 17277 17250 17252 17287 17307 17325 17285 17317 17288 17272 17299 17220 17321 17329 17341 17314 17293 17335 17328 17286 17366 17350 17306 17342 17096 17365 17309 17364 17349 17339 17369 17300 17390 17387 17361 17394 17376 17403 17359 17437 17415 17389 17382 17435 17423 17304 17449 17297 and 17241;   Model Number ASM500060: 16821 16820 16846 16865 16852 16862 16880 16774 16893 16888 16874 16924 16928 16927 16933 16926 16937 16934 16938 16844 16930 16969 16962 16963 16977 16925 16901 16945 17005 16986 16914 17020 16944 16885 17034 17019 16949 17057 17055 17058 16976 16965 16976 17047 16987 and 17070;   Model Number H3000WC: 16838 16849 16856 16850 16876 16869 16878 16811 16871 16889 16905 16898 16911 16921 16922 16910 16932 16886 16974 16955 16887 16919 16978 16968 16947 16979 16967 16972 16966 16970 17011 16994 17024 16950 17048 17042 17062 17018 17082 17105 17106 17000 17100 17125 17121 17025 17136 17122 17118 17041 17131 17103 17174 17164 17109 17197 17101 17114 16960 17199 17198 17124 17195 17179 17112 17185 17219 17238 17178 17247 17173 17265 16975 17259 17298 17260 17301 17278 17231 17165 17289 17290 17295 17333 17251 17338 17337 16946 17348 17373 17363 17347 17323 17326 17430 17416 17429 17415 17208 17422 17450 17258 and 17249; and   Model Number HH3000WD: 17072 17126 17067 17067 17107 17163 17236 17346 and 17379.

Radiology Devices

2

No

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.

GE Healthcare, Infinia Hawkeye¿ 4, Model Numbers: 5178728, ASM500060, || H3000WC and H3000WD. || 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.

Model Number: H3000WR, Lot Numbers:  16306 and 16275;  Model Number: H3000WW, Lot Numbers: 16086 16202 16231 16241 16268 16265 16247 16277 16201 16272 16274 16258 16278 16242 16257 16341 16307 16232 16351 16358 16363 16383 16134 16383 16367 16095 16359 16338 16390 16407 16253 16463 16242 16461 16484 16467 16472 16486 16393 16488 16507 16545 16459 16546 16523 16550 16521 16402 16417 16599 16556 16480 16558 16597 16555 16590 16603 16598 16606 16618 16630 16596 16530 16619 16609 16631 16623 16691 16708 16620 16633 16642 16599 16703 16591 16671 16764 16757 16604 16787 16615 16287 16690 16568 16458 16711 16727 16386 16729 16444 16260 16678 16687 16588 16700 16653 16730 16782 16824 16342 16879 16003 16801 16884 16292 16906 16892 16931 16952 16954 16222 16936 16895 16257 16951 16373 16958 16389 16982 16981 17038 16754 16985 16998 16855 16458 16644 and 16544,  Model Number: H3000WZ, Lot Numbers: 16237 16350 16251 16375 16387 16512 16565 16582 16403 16240 16183 16572 16485 16552 16248 16215 16261 16197 16468 16361 16624 16813 16409 16831 16481 16240 16264 16891 16961 16826 and 17148,  Model Number: H3000YM, Lot Numbers: 16046 16011 16021 16057 16027 16128 16077 16097 16019 16103 16082 16112 16029 16121 16157 16148 16159 16038 16147 16146 16127 16154 16174 16024 and 16133 and  Model Number: H3000YS, Lot Numbers: 16068 16089 16141 16085 and 16061.

Radiology Devices

2

No

Worldwide Distribution US (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, 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 the United Kingdom.

GE Healthcare Infinia Hawkeye¿, Model Numbers: H3000WR, H3000WW, H3000WZ, H3000YM and H3000YS. || Product 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.

Model Number: 5178728, Lot Numbers: 17445 17001 17035 17023 17008 16988 17007 17010 17063 17077 17053 16995 17088 17098 17090 16990 17054 17099 17081 17060 17128 17140 17116 17004 17089 17036 17045 17129 17130 17108 17093 17171 17144 17158 17069 17135 17040 17172 17132 17183 17153 17201 17182 17111 17190 17187 17175 17169 17133 17213 17166 17104 17203 17141 17204 17139 17113 17224 17226 17228 17210 17229 17119 17255 17239 17233 17002 17266 17245 17276 17264 17248 17094 17256 17273 17254 17281 17294 17305 17277 17250 17252 17287 17307 17325 17285 17317 17288 17272 17299 17220 17321 17329 17341 17314 17293 17335 17328 17286 17366 17350 17306 17342 17096 17365 17309 17364 17349 17339 17369 17300 17390 17387 17361 17394 17376 17403 17359 17437 17415 17389 17382 17435 17423 17304 17449 17297 and 17241;  Model Number: ASM00060, Lot Numbers: 16821 16820 16846 16865 16852 16862 16880 16774 16893 16888 16874 16924 16928 16927 16933 16926 16937 16934 16938 16844 16930 16969 16962 16963 16977 16925 16901 16945 17005 16986 16914 17020 16944 16885 17034 17019 16949 17057 17055 17058 16976 16965 16976 17047 16987 and 17070;  Model Number: H3000WC, Lot Numbers: 16838 16849 16856 16850 16876 16869 16878 16811 16871 16889 16905 16898 16911 16921 16922 16910 16932 16886 16974 16955 16887 16919 16978 16968 16947 16979 16967 16972 16966 16970 17011 16994 17024 16950 17048 17042 17062 17018 17082 17105 17106 17000 17100 17125 17121 17025 17136 17122 17118 17041 17131 17103 17174 17164 17109 17197 17101 17114 16960 17199 17198 17124 17195 17179 17112 17185 17219 17238 17178 17247 17173 17265 16975 17259 17298 17260 17301 17278 17231 17165 17289 17290 17295 17333 17251 17338 17337 16946 17348 17373 17363 17347 17323 17326 17430 17416 17429 17415 17208 17422 17450 17258 and 17249; and  Model Number: HH3000WD, Lot Numbers: 17072 17126 17067 17107 17163 17236 17346 and 17379.

Radiology Devices

2

No

Worldwide Distribution US (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, 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 the United Kingdom.

GE Healthcare Infinia Hawkeye¿ 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD. || Product 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.