Class 2 Device Recall Infinia, Infinia Hawkeye, Infinia II, Infinia Hawkeye 4

• Date Initiated by Firm: June 20, 2025
• Date Posted: July 08, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2097-2025
• Recall Event ID: 97193
• 510(K)Number: K022960
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
• Code Information: Serial Numbers: Infinia I 16143 16149 16179 16315 16335 16353 16826 17339 17799 18420 18442 18604 18605 18611 18624 18627 18628 18629 18637 18639 18641 18644 18645 18647 18648 18649 18650 18651 18652 18653 18655 18656 18657 193S08002; Infinia I Hawkeye 1 15006 15007 15013 16001 16003 16004 16005 16006 16007 16008 16009 16011 16012 16013 16015 16016 16019 16021 16022 16024 16026 16027 16028 16030 16033 16037 16038 16039 16043 16044 16048 16049 16050 16051 16052 16054 16057 16059 16060 16063 16064 16065 16070 16073 16074 16079 16081 16082 16083 16084 16087 16091 16099 16107 16109 16114 16123 16126 16127 16132 16134 16137 16140 16141 16148 16151 16153 16154 16155 16158 16159 16163 16164 16166 16168 16169 16171 16172 16173 16175 16177 16178 16182 16186 16433; Infinia II 16045 16094 16115 16135 16170 16190 16191 16194 16196 16198 16206 16207 16208 16209 16211 16212 16213 16214 16218 16220 16221 16223 16224 16227 16228 16229 16234 16235 16239 16244 16246 16250 16259 16262 16263 16271 16279 16285 16296 16303 16304 16305 16310 16312 16313 16318 16319 16322 16323 16324 16326 16334 16336 16355 16356 16365 16370 16371 16372 16376 16382 16404 16408 16411 16412 16413 16415 16418 16419 16421 16425 16426 16428 16434 16437 16442 16446 16455 16456 16457 16460 16465 16466 16469 16470 16474 16475 16478 16483 16489 16491 16497 16499 16500 16504 16509 16513 16525 16526 16528 16531 16533 16538 16539 16541 16542 16553 16557 16559 16560 16564 16566 16576 16579 16583 16585 16587 16592 16608 16611 16614 16621 16626 16627 16628 16632 16634 16635 16636 16639 16640 16643 16645 16646 16648 16649 16656 16657 16658 16659 16660 16661 16662 16663 16664 16665 16667 16668 16670 16672 16673 16677 16680 16683 16686 16692 16694 16695 16696 16699 16705 16706 16710 16712 16715 16716 16719 16720 16725 16732 16733 16734 16736 16738 16739 16743 16746 16748 16750 16751 16758 16760 16761 16766 16767 16768 16770 16772 16773 16775 16776 16779 16783 16786 16788 16789 16790 16792 16793 16794 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18557 18558 18560 18562 18601 18607 18608 18617 18622 18630 18631 18632 18633 18634 18640 18654 16477/16479; INFINIA II HAWKEYE 4 16106 16130 16199 16200 16201 16202 16204 16205 16215 16222 16226 16232 16242 16248 16251 16252 16254 16256 16258 16264 16265 16267 16270 16273 16277 16278 16280 16282 16287 16288 16292 16294 16299 16302 16309 16317 16325 16327 16328 16329 16330 16331 16333 16338 16341 16347 16348 16349 16350 16352 16357 16360 16361 16362 16373 16374 16383 16386 16388 16390 16399 16401 16402 16406 16409 16414 16417 16424 16429 16431 16432 16436 16438 16444 16445 16451 16461 16467 16481 16485 16488 16490 16493 16495 16496 16501 16506 16507 16514 16521 16535 16544 16546 16549 16551 16552 16554 16556 16558 16562 16565 16570 16572 16573 16577 16578 16590 16595 16597 16598 16599 16600 16602 16605 16606 16607 16609 16613 16615 16618 16620 16622 16623 16624 16633 16637 16638 16642 16644 16647 16652 16654 16676 16678 16679 16681 16684 16690 16700 16702 16703 16707 16709 16714 16717 16729 16753 16754 16757 16769 16771 16774 16780 16785 16808 16811 16813 16818 16820 16821 16824 16827 16835 16845 16849 16856 16869 16871 16874 16878 16883 16884 16886 16887 16888 16889 16891 16892 16894 16897 16899 16906 16910 16915 16921 16925 16927 16931 16938 16946 16949 16950 16953 16955 16956 16961 16962 16967 16975 16977 16980 16981 16987 16996 16997 17002 17005 17019 17020 17022 17023 17028 17029 17032 17033 17034 17037 17038 17042 17048 17049 17050 17052 17053 17055 17057 17058 17061 17062 17067 17068 17079 17082 17083 17085 17086 17090 17092 17098 17100 17101 17103 17104 17105 17107 17108 17110 17118 17122 17124 17126 17131 17135 17137 17138 17145 17149 17154 17156 17158 17161 17163 17165 17166 17169 17172 17174 17179 17181 17187 17190 17191 17194 17195 17204 17207 17209 17213 17214 17217 17220 17222 17226 17231 17236 17237 17238 17241 17244 17248 17249 17252 17258 17260 17262 17264 17265 17269 17278 17280 17284 17286 17287 17289 17290 17297 17299 17300 17301 17306 17310 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18610 18613 18614 18615 18616 18618 18619 18620 18626 18635 18638 18643 16764/18625 ***Updated 9/9/2026*** Additional serial nos. Infinia I 18593 INFINIA II HAWKEYE 4 17658
• FEI Number: 3004571294
• Recalling Firm/ Manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING; 4, Hayozma St; Tirat Carmel Israel
• For Additional Information Contact: GE HealthCare Service; 800-4371171
• Manufacturer Reason for Recall: Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
• FDA Determined Cause: Software design
• Action: Firm notified customers via Urgent Medical Device Correction letter dated June 20, 2025. Customers were instructed to check gantry software version. Instructions to do so are included in the letter. If system has the correct gantry software version, customers may continue to use their system--V.25BK for Infinia Running on Windows2000 (Win2K); C.15BK or C.1523 for Infinia on Windows XP; V.60BK on VG (all operating systems). If the software version is not the correct version, customers should discontinue use of system and contact GE HealthCare Service or local Service Representative. GE HealthCare will correct systems at no cost to the customer. Correction will include a hardware update and, if necessary, a software update. GE HealthCare representatives will contact customers to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
• Quantity in Commerce: 1822
• Distribution: Worldwide - US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KPS