Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65579

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 13, 2013
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
GE Healthcare, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is 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.

Z-1787-2013
Recall number
Z-1787-2013
Initiated
June 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
2474

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.

Code information

System ID: 1153389, 1299296, 2555007, 2621801, 2638808, 2694593, 2760723, 2768147, 2769200, 2775945, 2812777, 2827087, 2883051, 0828260003, 0828260005, 0828260006, 0828260007, 0828260009, 0828260011, 0828260013, 0828260015, 0828260017, 0828260018, 0828260019, 0828260020, 0834260003, 0834260008, 0834260012, 835260007, 0835260010, 0835260013, 0843260029, 0843260032, 0843260034, 0843260037, 0843260044, 0843260047, 0843260048, 0847260025, 0850260060, 0850260061, 0850260063, 0850260064, 0850260065, 0850260066, 0850260067, 0850260068, 0850260069, 0850260070, 0850260073, 0850260074, 0850260075, 0850260076, 0850260077, 0850260079, 0850260080, 0850260081, 0850260082, 0850260083, 0850260084, 0850260087, 0850260088, 0850260089, 0850260090, 0850260091, 0850260092, 0850260093, 0850260094, 0850260095, 0850260096, 0850260098, 0850260099, 0850260100, 0850260103, 0850260104, 0850260105, 0850260106, 0850260107, 0850260108, 0850260109, 0850260110, 0850260111, 0850260112, 0850260113, 0850260114, 0850260115, 0850260117, 0850260119, 0850260120, 0850260121, 0850260123, 0850260124, 0850260127, 0850260129, 0850260130, 0850260133, 0853260020, 0853260023, 0853260024, 0853260025, 0853260029, 0853260030, 0853260032, 0853260035, 0853260036, 0853260039, 0853260040, 0853260042, 0853260045, 0853260046, 0853260056, 0853260062, 0853260066, 0853260069, 0853260072, 0853260074, 0853260087, 0853260100, 0853260103, 0853260105, 0853260113, 853260118, 0853260119, 0856260023, 0856260024, 0856260025, 0856260026, 0856260028, 856260029, 0856260030, 0856260031, 0856260032, 859260010, 0910262170, 0910262196, 0910262205, 0910262210, 0910262214, 0910262217, 0910262220, 0910262225, 0910262227, 0910262229, 0910262234, 0910262236, 0910262239, 0910262241, 0910262244, 0910262249, 0910262255, 0910262257, 0910262263, 0910262266, 0910262269, 0910262276, 0910262279, 0910262280, 0910262285, 0910262288, 0910262291, 0910262293, 0910262295, 0910262301, 0910262307, 0910262312, 0910262332, 0910262335, 0910262338, 910262349, 0910263135, 0910263143, 0910263157, 0910263159, 0910263161, 0910263166, 0910263190, 0910263198, 0910263204, 0910263207, 0910263210, 0910264058, 0910264060, 0910264062, 0910264067, 0910264069, 0910264072, 0910264075, 0910264077, 0910264079, 0910264081, 0910264083, 0910264085, 0910264089, 0910264091, 0910264095, 0910264098, 0910264100, 0910264102, 0910264105, 0910264107, 0910264112, 0910264115, 0910264121, 0910264123, 0910264126, 0910264129, 0910264136, 0910264137, 0910264145, 0910264152, 0910265050, 0910265053, 0910265055, 0910265059, 0910265063, 0910265066, 0910265068, 0910265072, 0910266042, 0910266045, 0910266050, 0910266053, 0910266063, 0910266067, 0910267010, 0910267015, 0910267020, 0920269079, 0920269081, 0920269082, 0920269087, 0920269092, 0920269093, 082426010014, 082426020005, 082426030020, 082426030021, 082426030022, 082426040030, 082426040033, 082426040034, 082426040035, 082426040036, 082426040037, 082426040038, 082426040039, 082426040041, 082426040042, 082426040045, 082426040048, 082426040049, 082426040050, 082426050004, 082426050005, 082426050007, 082426070018, 082426070019, 082426070020, 082426070022, 082426070023, 082426070024, 082426070025, 082426070033, 082426080010, 082426080012, 082426080014, 082426080018, 082426080019, 082426090016, 082426090017, 082426090018, 082426090020, 082426090021, 082426090022, 082426090023, 082426090024, 082426090026, 082426090027, 082426090028, 082426090033, 082426100028, 082426100032, 082426100033, 082426100035, 082426100036, 082426100037, 082426100038, 082426100041, 082426100043, 082426100044, 082426100046, 082426100047, 082426100048, 082426110004, 082426110006, 082426110007, 082426110008, 082426110009, 082426110010, 082426120006, 082426120007, 082426120011, 082426120013, 082426120015, 082426120016, 082426120017, 082426120018, 082426120019, 082426120020, 082426120021, 082426120022, 082426130020, 082426130021, 082426130023, 082426130024, 082426130025, 082426130026, 082426130027, 082426130031, 082426130032, 082426130033, 082426130034, 082426130035, 082426130037, 082426130038, 082426130039, 082426140016, 082426140017, 082426140018, 082426140019, 082426140020, 082426140021, 082426140022, 082426140023, 082426140024, 082426150012, 082426150013, 082426150014, 082426150015, 082426150016, 082426150018, 082426150019, 082426150021, 082426150022, 082426150023, 082426150024, 082426150025, 082426150029, 082426150030, 082426150031, 082426160025, 082426160026, 082426160027, 082426160030, 082426160031, 082426160032, 082426160033, 082426160034, 082426160035, 082426160036, 082426160038, 082426160039, 082426160040, 082426170003, 082426180007, 082426180009, 082426180010, 082426180011, 082426180013, 082426190014, 082426190015, 082426190016, 082426190017, 082426190020, 082426200003, 082426200004, 082426200007, 082426200008, 082426200009, 082426210013, 082426210015, 082426210016, 082426210017, 082426210019, 082426220007, 082426230015, 082426230016, 082426230017, 082426230018, 082426240003, 082426250003, 082426270005, 082426270006, 082426270007, 082426270008, 082426290005, 082426290006, 082426290008, 082426310015, 082426310016, 082426310019, 082426310021, 082426310022, 082426310024, 082426310025, 082427140029, 083026002000469, 083026002000938, 083026002002289, 083026002100219, 083026002100286, 083026002101088, 083026003811611, 083026006866397, 083026008153639, 083026022002291, 083026022002299, 083026026463911, 083026062000397, 083026062102318, 083026102101827, 083026202100317, 083026202100886, 083026202100929, 083026202101361, 083026202102248, 083026202592007, 083026206522477, 083026242101977, 083026600020711, 083026602100924, 083026602100925, 083026602101279, 083026602101643, 083026602101669, 083026602634522, 083026608462741, 083026801003210, 083026802100537, 083026802101686, 083026805120043, 083026822100376, 083026822100655, 083026822100665, 083026822101249, 083026842101377, 083026842101817, 083026861008410, 083026862100378, 083026862100513, 083026862100874, 083026862101014, 083026867892981, 083026867892988, 00002NUC02, 00013NUC01, 00018NUC04, 00034NUC01, 00053NUC06, 00053NUC09, 00065NUC05, 00067NUC01, 00100NUC02, 00105NUC03, 00109NUC01, 00109NUC04, 00116NUC01, 00130NUC03, 00130NUC04, 00131NUC03, 00133NUC21, 00136NUC03, 00136NUC08, 00141NUC06, 00165NUC04, 00169NUC07, 00171NUC04, 00186NUC02, 00187NUC01, 00197NUC11, 00203NUC03, 00216NUC11, 00231NUC09, 00234NUC05, 00240NUC05, 00253NUC02, 00257NUC06, 00257NUC15, 00260NUC03, 00263NUC08, 00271NUC04, 00289NUC02, 00311NUC01, 00313NUC01, 00318NUC03, 00318NUC10, 00331NUC02, 00348NUC02, 00361NUC05, 00371NUC04, 00373NUC01, 00374NUC05, 00379NUC01, 00383NUC03, 00393NUC06, 00433NUC09, 00439NUC08, 00440NUC07, 00440NUC09, 00440NUC11, 00487NUC04, 00669NUC01, 01002NUC04, 010120NU11, 01012NUC01, 01042NUC01, 01243NUC02, 01344NUC01, 01367NUC01, 030010NU05, 030018NU05, 030037NU04, 030057NU05, 030078NU13, 030151NU12, 030209NU02, 030232NU10, 030232NU13, 030240NU07, 030388NU04, 030419NU09, 05217NUC05, 05452NUC03, 06008NUC09, 06014NUC02, 06051NUC01, 06051NUC04, 06109NUC01, 06109NUC02, 07015NUC01, 080004NU11, 080004NU13, 080026NU08, 080053NU02, 100029NU01, 10181NUC06, 10448NUC04, 10497NUC01, 10497NUC03, 10627NUC01, 110009NU01, 110022NU03, 110034NU04, 110064NU01, 110093NU07, 11018NUC04, 130083NU13, 130139NU02, 150017NU05, 1577INFINIA, 160150NU04, 17005NUC01, 18076INFINIA, 190052NU06, 190057NU05, 190057NU10, 190073NU01, 190171NU05, 190187NU01, 190194NU01, 190205NU06, 190282NU09, 202715INF4, 203325INF, 203325INF2, 203384INF, 203688INF, 203797INF, 203852INF, 204787INFINIA, 204787INFINIA2, 204837HK1, 204837IN1, 205408INF2, 205750INF, 205759INF, 205783INF1, 205939INF, 206223INF, 206223INF2, 207255INFINIA, 207795INFINIA, 208422INF, 209223IN, 209385IN, 209526IN, 209831IN, 210036NU06, 21011NUC01, 210358IHE, 210575INF1, 210617NM1, 210705NM1, 210757NM1, 210921NM1, 210MTINFINIA, 212241INF1, 212241INF2, 212241INF3, 212562INF1, 212608INF1, 212686INF1, 212989INF1, 214324INF, 214370INF, 214820INF1, 214820INF2, 214879INF, 215427INFINIA, 215537INFINIA, 215707INFINIA, 215710INFINIA, 215728INFINIAJ, 215952INF, 215952INF2, 217223INF1, 217223INF2, 217347INF2, 217347INFINIA, 217528NUC, 217544NUC1, 217554CINF, 218847INF, 220826NU01, 225381INF, 225647INF, 225658INF, 225765INF1, 225INFINIA, 225NOINF, 228436INF, 228523HWK, 228523HWK2, 228818INF, 228865HWK, 229259INF, 229333ICINF1, 229333ICINF2, 229SUMINF, 23002NUC01, 23003NUC01, 231935INF, 239NCHINF1, 240566INF, 248465INF, 248471INF, 248849INF1, 248849INF2, 248898INF, 248898INF2, 250339INFINIA4H, 250370INFINIAH4, 250565NUC4, 250727INFINIA1, 250754INFINIA, 250754INFINIA2, 250785INF1, 252436INF1, 2543334INFINIA, 254519NMINF, 254743NM, 254743NM2, 256327NUC, 256341NRM1, 256386HKNM2, 256429INF1, 256494NM1, 2565059INFINIA, 256543INF1, 256761INF, 2583615INF, 2585033INF, 259170NU02, 260010NU05, 2605823INF, 2612588INF2H, 262010NU01, 262329INF, 262334INF, 262363INF, 262434INF1, 262434INF2, 262569INF, 262574INFIN, 262574INFIN3, 262656INF1, 262656INF2, 262670INF2, 262687INF, 262687INF2, 262741INF, 262741INF2, 262767INF, 262948INF, 26329NM1, 2633201INF, 2646005INF, 2660585INF, 269223VABCINF, 2694427INF, 269657SHINF, 270651INF1, 270688INF, 2721482INF, 2723INFINIA, 2750751INF, 2766055INFHE4, 281251SLVINF, 281274DINF, 281274INF, 281338INF1, 281348INF, 281420INF, 281599INF1, 281637INF, 281897INF1, 2864298INF, 2919654INF, 2928217INF, 2954INFINIA, 2962725INFINIA, 300013NU01, 301295INF1, 301295INF2, 301714INF, 301877INF, 302428INF, 302629INF, 302733INF, 302744INF1, 303320IH, 303399IH, 303450INF, 303837INF, 303839INF, 304264INF, 304623INF1, 304623INF2, 304637INF, 304831LNM1, 305227INF1, 305227INF2, 305325INF, 305575INF1, 305575INF2, 305682INF1, 305835INF, 305VAMIAMI, 306655INFINIA, 306655INFINIA2, 306655INFINIA3, 306655INFINIA4, 306655INFINIA5, 306766INF1, 306766INF2, 307332INFINIA, 309344SMNUC, 309655INF1, 309779INF, 310319INF1, 310543INF1, 310832INF1, 312996INF, 313343INF1, 313343INF2, 313343INF3, 313343INF4, 313473INF, 314525INF1, 314525INF2, 315425INF, 316268VCFI, 316268VCFI2, 316858GI, 316962WI, 317338HAWK, 317415INF, 318327INF1, 318330INF1, 318388INF1, 318681INFINIA, 318681INFINIA2, 318798INFINIA, 319272INF, 319356INF, 319768INF, 319768INF2, 323268INF1, 325235NUC, 330343INFINIA, 330344INFINIA1, 330363INFINIA1, 330363INFINIA2, 330363INFINIA3, 330721INFINIA1, 330721INFINIA2, 337289INF, 337436INF, 337981INF, 34006NUC03, 34017NUC01, 34017NUC02, 34021NUC02, 34094NUC02, 34284NUC04, 34318NUC01, 34329NUC01, 34335NUC01, 34340NUC01, 34351NUC01, 35003NUC04, 35003NUC05, 352333INF, 352344INF, 352596INF1, 360PSPHINF1, 361572NM1, 361595SKI1, 361694DNMINF, 361881SSINF1, 361985SNM, 36INF2753220, 38001NUC01, 38001NUC02, 386326INF1, 386362INF1, 3882942310MNCTR, 401444INF, 402354HWK, 402354INF, 402449INF, 402461INF, 402559INF1, 402559INF2, 403229INFINIA, 403251INFINIA1, 403289NUC1, 403289NUC2, 403382INFINIA1, 403382INFINIA2, 403541INFINIA, 403670NUC8, 403777INFINIA, 403777INFINIA2, 403777INFINIA3, 404265INF, 404321INF, 404466INF, 404605INF, 404686INF, 404712INF, 405271IH1, 405271VAINF1, 405307INF1, 405610MINF1, 405742INF1, 406228FINF, 406238INF, 406731INF1, 408259IN1, 4082IN, 408315IN, 408315IN2, 408559IN1, 408851IN, 409727NM1, 409938INF, 409985NMI1, 41009NUC01, 410337INF, 410337INF2, 410337INF3, 410550INF, 410605INF, 410822HK1, 410955INF, 412343INF1, 412372INF1, 412653INF1, 412692INF1, 412692INF2, 414325INF, 414384INF, 414489INF, 414649INF, 414805QUA, 414ISCINFIN2, 414ISCINFINIA, 415222IN1, 415300IN, 415353IN, 415353IN2, 415677INF, 415750IN1, 415838IN, 415925INF, 416444INFINIA1, 416469INHE4A, 416469INHE4B, 416633INFINIA, 416756INFINIA, 416756INFINIA2, 416813INFINIA, 416864INFINIA1, 416864INFINIA2, 416928INFINIA, 417256INF, 418275INFINIA, 418589INFINIA, 418649NUC1, 419227I1, 419227I2, 419238INF, 419383NM1, 419423NUC, 419455INF1, 419483NUC2, 419933I1, 423472INF, 423493PINF, 423553INF, 423625INFINIA, 423778EDINF, 423778MMINF, 425261INF, 427459NU02, 432685DNUC, 434924INF1, 434924INF2, 434924INF3, 435251INF1, 435251INF2, 435658INF, 435750INF2, 435781INF1, 435893INF, 44014NUC01, 441236INFINIA, 443481BINF, 443481INF, 443481INF2, 45001NUC01, 45011NUC01, 450468INFINIA, 450654INF1, 450654INF2, 450654INF3, 450746INFINIA, 469764INF, 4716INFINIAHE4, 475290NU01, 478272INF, 478454INF, 478633INFINIA, 478633INFINIA2, 479441INF1, 479463INF, 479463INF2, 479549INF, 479553INF, 479751INF, 479967INF, 480301NM1, 480323INFRM1, 480323INFRM2, 480323INFRM3, 480324INF, 480512INF1, 480512INF2, 480882INF1, 480882INF2, 484503INFINIA1, 485520NU01, 485520NU07, 493519NU01, 493519NU02, 501202INF, 501620INF, 501776INF, 502259INF, 502287INF, 502350INF, 502624INF, 502868INF1, 502893INF, 502955INF, 503435INF, 503561HK4, 503561INF, 504380INF, 504454INF, 504537INF, 504826INF, 504838INFH, 504873INF, 504873INF2, 505262INF, 505609INFINIA, 505863INF, 506544NUCGE, 506739INFINIA, 506739INFINIA2, 507345INF1, 507402INF1, 507434INF1, 507457INF1, 507OLMINF1, 508427INF2, 508427INFINIA, 508457INF, 508674INFINIA, 508828INF, 509473INFINIA, 509474INFINIA, 509946INF, 510400IN, 510437IN, 510537IN1, 512324NM, 512397INF, 512528NM1, 512LRMCNM, 513298INF1, 513298INF2, 513454INF1, 513585INF, 513636INF, 513867INF, 514252AINFINIA1, 514252AINFINIA2, 514252AINFINIA4, 514252AINFINIA6, 514340INFINIA, 514371INFINIA, 514495INFINIA, 514842AINFINIA, 514842AINFINIA2, 514934AINFINIA, 515247INF1, 515247INF2, 516562INFINIA1, 516562INFINIA2, 516570INF, 516622INFINIA, 516IPKINF1, 517543INF, 518262INF1, 518262INF2, 518262INF3, 518271INF, 518562INF, 518626INF, 518773INF, 518828INF, 518926INF, 519631INFINIA, 519663INFINIA2, 519685INFH4, 519685INFINIA, 519685INFINIA2, 519749INFINIA, 519749INFINIA2, 519752INFINIA, 519752INFINIAH4, 519965INFINIA, 52006NUC01, 520868INF, 520VAINF1, 529150NU03, 529150NU04, 530225IN, 530533IN, 530876IN, 540213INF1, 540332INF1, 540332INF2, 540332INF3, 540498INF1, 540536INF1, 540536OCHAWK, 540689INF1, 540689INF2, 540741HAWK1, 540741INF1, 541296HK4, 541387INF, 541440INF, 541754HK4, 559225IN, 559353IN, 561650INF1, 561744INF, 561744INF2, 562826INFINIA, 570398INF, 570501INF, 570552INF, 570621INF, 570621INF2, 570836INFINIA, 571231HAWK1, 571231INF1, 571231INF2, 573686INF1, 573686INF2, 580249IN1, 580931INF1, 585922INF1, 586226INF, 586416INF, 600042NM05, 600042NM06, 600044NM07, 600055NM04, 600092NM10, 600131NM05, 601288INF1, 601376INF1, 601443INF1, 601936INF1, 601978INF, 602239INF1, 602344NM1, 602406INF, 602406INF1, 602406INF3, 602406OPINF, 602588INF, 603650INFINIA1, 603924INF, 604228INFINIA1, 604278INFINIA1, 604278INFINIA2, 604434INFINIA, 604520INFINIA1, 604520INFINIA2, 604520INFINIA3H, 604520INFINIA4H, 604531INFINIAH, 604557INFINIAH1, 604557INFINIAH2, 604557INFINIAH3, 604588INFINIA1, 604588INFINIA2, 604588INFINIA3H, 604588INFINIA4H, 604875INFINIA1, 604875INFINIA2H, 605333INF2, 605333INF3, 605333INF4, 605333INF5, 605333INFINIA, 605353NM, 606878INF1, 606878INF2, 607274INF, 607274INF2, 607737INF, 607756INF, 607756INF2, 607762INF, 607763INF, 608263INF, 608263INF2, 608263INF3, 608324INF, 608756INF, 608775INF1, 608775INF2, 608775INF3, 608791INF, 609267INF, 609652INF, 609730INF1, 609730INF2, 609835INFINIA, 610278INFINIA, 610327INFINIA, 610402INFINIA, 610402INFINIA2, 610437INFINIA, 610770INFINIA, 610869INF, 610954INFINIA, 613727INFIN, 613761INFINIA, 613969HAWKEYE, 613969INFINIA, 614478INF1, 615284INF1, 615322NM3, 615327VANM1, 615328NM1, 615342INF1, 615349NM1, 615349NM2, 615768SCNM1, 615769NM1, 615781NM1, 615893NM1, 615896NM1, 616267INFINIA, 617243INFINIA, 617296INF, 617313INF1, 618234INF1, 618256INF1, 618395INF, 618544INF, 618942INF, 618993INF, 619229INF, 619482INFINIA, 620225WPI, 620232INF, 623207INF, 623478NM2, 623848NM2, 623882INF, 626359INF1, 626359INF2, 626570INF1, 626573INF1, 626898INF1, 626915INF1, 63009NUC01, 630275INF, 630275INF2, 630312INF, 630545INF, 630786INF, 630801INF, 630856INF, 6502IN1, 6502IN2, 650367IN1, 650725IN, 650725IN2, 650858IN1, 650858IN2, 650858IN3, 651241INF1, 6525011INF1, 661633NM1, 661949NUC1, 661PMCNUC1, 662244INFINIA, 662256INFINIA, 662377INFINIA, 662423INFINIA, 662608NU01, 662772INFRM1, 662772INFRM2, 662772INFRM4, 671USNHINF, 678474INF, 681342INF1, 681342INF2, 681342INF3, 681342INF4, 70027NUC03, 70060NUC12, 701234INF, 701234INF2, 701364INF, 701774NM, 701857NM, 701952NM, 702255INF, 702360CHNM, 702369NM, 702388VNM, 702853NM, 703391INF1, 703391INF2, 703504HAWK1, 703558INF, 703689INF4, 703698INF1, 703858HAWK, 703858INF, 704225INF1, 704225INF2, 704304INF1, 704304INF2, 704316INFI, 704355INF1, 704355INF2, 704384HAWK1, 704384INFI2, 704384INFI4, 704384INFI5, 704384INH1, 704446INF1, 704487INFINIA1, 704660HAWK, 704667INF1, 704739INFI, 704783INFI1, 704783INFI2, 704783INFI3, 704863INF1, 705674HAWKEYE, 705674INFINIA, 705759HAWKEYE, 705759INFINIA2, 706278INF, 706291HINM, 706494HNM, 706651INF, 706651NUC, 706733INF, 707822INFINIA, 707963IN, 708660INF, 708684INF1, 708747INFACQ, 709637INFINIA1, 709651INFINIA, 709651INHE4A, 709737INFINIA, 709737INFINIA2, 709737INFINIA3, 712279INF, 713242INF1, 713242INF2, 713242INF3, 713359INF1, 713456INF, 713722INF, 713785SLINF1, 713785SLINF2, 713785SLINF3, 713794INF, 713794INF2, 713794INF3, 713ACCINF1, 714456INFINIA, 714953INFINIA, 715423INF, 715623INF, 715839INF, 716366INF, 717544INFINIA, 717627INFINIA, 717633INF1, 717633INF2, 717782INF, 718150INF1, 718240INF1, 718240INF2, 718250INF1, 718334INF1, 718334INF2, 718405INF1, 718518INF1, 718584INFINIA, 718616INF, 718630INF1, 718883INF1, 718883INF2, 718948INF, 718963INF1WH, 719333IH, 722050NU01, 724226INF1, 724357INF1, 724450INFINIA, 727461VG, 727521INF, 727581INF, 727843INF1, 727863INF1, 727893INF, 727942INF, 731425INFH1, 731425NMIC1, 731425NMRM, 731644INF, 732292INFINIA, 732321IH4, 732321INFINIA, 732530INFINIA, 732530INFINIA2, 732776INFH4, 732840INFINIA, 732923INFINIA, 732937INFINIA, 734246INF, 734467INF, 734475INF, 734671INF, 740264INF3, 740264INF4, 740356INF1, 740356INF2, 740383INF1, 740623INFINIA, 740922INFINIA, 740944NU01, 757259INF1, 757312INF1, 757312INF2, 757388INF2, 757395INF1, 757398INF1, 757398INF2, 757668INF1, 757722INF1, 757886INF1, 757889INF1, 760241INF1, 760452INF1, 760778INF1, 760873NUC, 763MRCYINFI, 763UNTYINFI, 765456INF, 765552INF, 770219INF, 770229INF, 770382INM, 770400INF, 770535INF1, 770751INF, 77137NUC01, 77139NUC05, 77187NUC01, 77260NUC03, 772LMCNM2, 773665INF1, 773665INF2, 77383NUC03, 773884INF, 773947INF, 773995INF, 774442INF, 775423INF1, 77624NUC01, 77624NUC03, 780489INFINIAH4, 780489INHE4B, 780489INHE4C, 780715INHE4A, 780875INFINIA, 781340INF, 781340INF2, 781340INF3, 781477INF, 781979INF1, 783348NU01, 785462CI, 786308INF1, 786308INF2, 787653INFINIA2, 787758INFINIA2, 787764INFINIA-1, 787848INFINIA, 78NMIH2564713, 801268INF1, 801299INF1, 801314INF1, 801357INF1, 801357INF2, 801387INF1, 801408INF, 801408INF2, 801465INF1, 801479INF, 801479INF2, 801501INF1, 801584INF1, 801584INF2, 801584INF3, 801588INF, 801ALTAINF2, 801IMCCARD, 801IMCINF, 801IMCINF1, 801RHINF, 801SLCINF, 802257INF, 802388INF, 802775INFINIA, 803329HAWK, 803329INFIN1, 804225INF1, 804254INF, 804281INF1, 804323INF1, 804594INF1, 804675INF1, 804957INF1, 804957INF2, 805370INF1, 805489INF1, 805543INF1, 805737INF1, 806354ACINFINIA, 806354NWINF, 806354NWINF2, 806GRACENM, 809758INFINIA, 812265KDINF, 812426INF, 812485INF, 812522INF, 812842INF1, 813788INF1, 813870INF, 813USFINF1, 814333INFINIA1, 814333INFINIA2, 814362INFINIA, 814452INF1, 814467INF, 814533INF, 814534INF1, 814643INF, 814723INF, 814877INFINIA, 814889INFINIA, 815395INF, 815432INF, 815432INFINIA, 815741INF1, 815741INF2, 815756INF, 816271SJINF, 816348INF1, 816380CASSINF, 816392RINF, 816404INF1, 816836CIIN, 817255INF, 817346INF, 817472INF, 817599INF, 817685INF, 817920INF, 818409INF2, 818884INF1, 818907INF1, 819357BINFINIA, 819378INFINIA, 819537INFINIA, 819537INFINIA2, 819563CINFINIA, 819595INFINIA, 828262INFINIA, 828286INFINIA, 828298HAWK1, 828298HAWK2, 828315HWK4, 828586INFINIA, 828696INFINIA1, 828766INFINIA, 828883INFINIA, 831755IN1, 832505NM1, 832522INF, 832522INF2, 832824INF, 843402INF, 843402INF2, 843412INF, 843431IN, 843606INF1, 843674IN1, 843674IN2, 843674IN3, 843689INF, 843692IN1, 843724INF, 843724INF2, 843777IN1, 843777IN2, 843777IN3, 843782INF, 843797INF1, 843832INF, 845794INFINIA, 845987INFINIA, 847480INF, 847535INFACQ, 847990INF1, 849010NU01, 850494HAWK, 850883ENM, 856247INF, 856363INFINIA, 858554EDCINF, 858554INF1, 858554INF2, 859268INF1, 859313INF, 859498INF1, 860344INF, 860350INIF, 863679INF1, 863680INF1, 863687INF1, 863687INF2, 864560HAWK1, 864675HAWK, 864675INFI, 864SPAHK1, 864SPAHK2, 865271NM1, 865373INF, 865429INFINIA, 865545INFINIA1, 865717INF, 865947INFINIA1, 865977INF, 876259NU01, 885INFI1, 885INFI2, 900010NU06, 901287INF1, 901495INFHAWK, 901495INFINIA, 901516NINFHK, 901516UINFHK, 901523INF1, 901523INF2, 901765INFRM8, 902567NUCINH4, 903416INF, 903731INFINIA, 903785INF, 903UTINF, 904202INF1, 904276INF1, 904321INF1, 904542NM, 904627INF1, 904627INF2, 904819INF1, 904821INF3, 904821NM1, 904821NM2, 905358INFINIA, 905372INFINIA, 905472INFINIA, 905472INHE4A, 905521INFHE4, 905522INFINIA, 905522INFINIA2, 905577INFHE4A, 905577INFHE4B, 905683IN1, 905731INFINIA, 905773INFINIA1, 905813INFINIA, 905813INFINIA2, 905832INFINIA, 905845INFINIA1, 905848INFINIA, 905855INFINIA, 905855INFINIA2, 905855INFINIA3, 905883HAWKEYE, 905895INFINIA1, 905895INFINIA2, 906293INF, 906774INF, 906776INF, 907562NM1, 907562NM2, 908522INFINIA, 908522INFINIA2, 908522INFINIA3, 909825INFINIA, 910323INF1, 912486EGNC, 912691SCNC, 913345INF1, 913541INF1, 913588INF, 913588INF1, 913588INF2, 913676SMIM, 915521HNM1, 915577NM1, 915595GNM1, 916453IN, 916537IN, 916537IN2, 916703IN1, 916703IN2, 916733IN, 916781IN, 916782IN1, 916782IN2, 916983INFN1, 918294INF1, 918307INF1, 918307INF2, 918376INF1, 918494INF1, 918494INF2, 918494INF3, 918502INF1, 918599INF1, 919684INF1, 919684INF2, 919684INF3, 919784INF1, 919934INF, 920288INF, 920288INF2, 920451INF, 920456INF, 920568INF, 920684INF, 920729INF, 920738INF, 920738INF1, 920738INF2, 920794INF, 920849INF, 920907INF, 925370IN, 925779IN, 925785IN, 925INF, 928214INF, 928442INF, 928537INF, 928855INF, 931381NM2, 931403NM1, 931967NM, 937208INF1, 937208INF2, 937268INF1, 937278INF, 937328INF1, 937328INF2, 937374INF1, 937386INF, 937390INF1, 937393INF, 937438INF, 937440INF1, 937440INF2, 937832INF1, 941235INF, 941629INF, 941637INF, 941766INF2, 941VRMCINF, 951672INF1, 951696INF1, 954265INF1, 954735INF1, 954735INF2, 954978INF1, 956350NM1, 956687INF2, 956971NM1, 970350IH, 970945INF, 972394INF, 972498INF, 972540INF, 972596INF, 972969INF, 973579INFINIA, 973625INFINIA, 973676INFINIA, 973831INFINIA, 973877INFINIA, 973971INFINIA, 978521INF, 979241INF, 979532INF1, 980212INF1, 985230INF, 985646INF, 985649INF1, 985649INF2, 985785INF, 989723INF1, 989723INF2, A004NU11, A186363001, A4169304, A4194407, A51043155, A51043187, A5107756, A5107766, A5109126, A5109665, A5109666, A5111127, A5111240, A5112411, A5113627, A5114292, A51149103, A5115111, A51152163, A51152164, A5118056, A5118088, A5120724, A5123523, A5124139, A5127292, A5128755, A5128757, A5129026, A5129959, A5152964, A5153612, A5162248, A5172907, A5172908, A5178021, A5181660, A5181662, A5189714, A5197927, A5197934, A5198016, A5215935, A5216823, A5216824, A5224207, A5267107, A5279301, A5279302, A5306502, A5315551, A5352208, A5367805, A5547414, A5634003, A5649008, A5719812, A58080111, A58080134, A5924402, A99263311, AC001NU14, AC001NU18, AF1026NM01, AH1908NU01, AH1908NU02, AH3403NU01, AH3701NM05, AH4307NM05, AH4660NM06, AH5117NU02, AH5249NM04, AH5293NM04, AH5689NU01, AH5689NU03, AH5689NU04, AH5844NM05, ALM0131, AMS0338, APL0232, ARHINFI, B1650218, B1768001, B4155415, B4182004, B5119121, B5142302, B5142304, B5174320, B5315345, B5357630, B5365422, B5395703, B5483443, B5618331, BCHINF1, BRMCINF, C001NU06, C001NU10, C4191749, C4191765, C5120912, C5120915, CC3899NU01, CE561221, CFRHINF, CHAM01NU01, COR359309, COR369576, COR373273, COR373282, CRAVENINF1, CRAVENINF2, CRAVENINF3, CS1008NM03, CS1021NM03, CS1052NM08, CS1052NM09, CS1277NM01, CS1277NM02, CS1318NM01, CSNMINFINIA, CY1015NM01, D5111602, D5111607, DE492A51, DE528467, DE539254, DE6588112, DEH13556, DEN01721, DEN01723, DEN01725, DEN01727, DHG0539, DK1022NM05, DK1023NM03, DK1023NM05, DK1026NM07, DK1026NM08, DK1029NM05, DK1065NM04, DK1065NM05, DPN00002, DVT0138, DZ1035NM03, DZ1035NM04, DZ1147NM01, DZ1279NM01, DZ1338NM01, E001NU16, E4858901, EE1019NM02, EE238526, EEF51540, EG1100MN01, EG1124MN02, EG1538MN01, EG1826MN01, EMM0131, F5119151, FE443890, FEB33835, FEE12426, FEG46134, FHEINF, FI1000MN04, FI1003MN05, FI1003MN06, FI1010NM01, FI1019MN01, FI1021MN01, FI1023MN02, FI1029MN01, FI1064MN01, FI1153MN01, FPG86405, G4191710, GE1004NM01, GILESINF, GOLD001642, GOLD010343, GOU0137, GOU0138, GPQ19105, H002NU01, H010NU04, H010NU08, H2094NUC07, H2094NUC28, H2100NUC02, H2193NUC13, H4858974, HC0074NU01, HC0507NU03, HC0842NU01, HC0863NU01, HC0892NU04, HC1249NU01, HC1249NU02, HC1819NU01, HC2252NU01, HC2720NU02, HC3442NU01, HC4387NU02, HC4480NU01, HC7475NU03, HDB0130, HGL0233, HGV0130, HLUE01NU01, HLV0334, HR4103NM01, HU1039NM02, HU1099NM01, IE1006MN04, IE1029MN04, IE1029MN05, IE1053MN01, IE1085MN05, IE1100MN01, IE1110MN01, IE1510MN09, IE1510MN12, IE1510MN16, IE1564NM01, IE1564NM03, IL1018NM07, IL1018NM08, IL1020NM25, IL1020NM31, IL1028NM26, IL1041NM18, IL1041NM22, IL1041NM28, IL1041NM29, IL1042NM09, IL1043NM20, IL1059NM07, IL1062NM26, IL1068NM05, IL1069NM06, IL1069NM11, IL1331NM01, INF2649553, IR1049NM01, IR1501NM01, JO1034NM01, JOHNINF, KW1001MN23, KW1001MN25, KW1005MN11, KW1005MN14, KW1006NM01, KW1013NM01, KW1013NM02, KW1018MN05, KW1018MN06, KW1018MN08, LB1122NM02, LDD0431, LDD0433, LGMCINF, LGMCINF2, LT4000MN01, LT4000MN02, LV4002NM02, M1106608, M1279727, M1400803, M1804913, M1804914, M204493801, M2147255, M218669001, M2269829, M23084315, M256517203, M2645705, M2846905, M4018099, M4018536, M4023087, M4024095, M40345193, M4040544, M4111216, M4135141, M4135145, M4143953, M4144332, M4144340, M4145143, M4159227, M4159228, M4159235, M4159460, M4160449, M4163763, M4167153, M4184856, M4191430, M4194031, M4198189, M4215553, M4234232, M4234235, M4479619, M4480229, M4480232, M44827146, M4496943, M5172527, M54606103, M7411101, M7411106, M8572211, M9162716, M9164758, M9319116, M9886832, MA1020NM01, MA1272NM01, MA1439NM01, ME051533, ME208350, ME244391, ME244393, MEX68919, MPP0131, MPX46902, MPX47106, MPX52309, MPX82204, MPX99201, MQ1000MN04, MT1014NM01, MT1014NM02, MVINFNM2, N001NU02, N001NU06, NA1027NM01, NASHNM2, NE209938, NM156449, NM18342, NM18346, NM18356, NM18357, NM18363, NM18365, NM18409, NM18444, NM18451, NM18471, NMCR-17849, NMCR-17980, NMINDTCRL0206, NMINDTCRL0227, NMINDTCRL0311, NMINDTCRL0351, NO1000MN03, NO1000MN06, NO1016MN16, NO1054MN01, NO1068MN07, NO1068MN09, NO1070MN07, NO1088MN09, NO1116MN09, NP739716, NPV15964, NUC5178133HM6, O005NU14, OBNM1, ORMCINFINIA1, ORMCINFINIA2, P4211482, PC1268NU03, PC1818NU03, PC3906NU02, PC3964NU02, PC3970NU02, PC5995NU01, PC8118NU01, PER03520, PER08009, PITTINF4, PITTINF5, PK1001NM01, PK1031NM01, PK1032NM01, PK1180NM03, PK1180NM08, PK1184NM01, PK1278NM01, PK1307NM01, PK1335NM01, PK1336NM01, PK1355NM01, PL1003NM03, PL1143NM03, PL1143NM06, PL1692NM01, PM1633NU03, PMR12506, PPR08202, PPR12213, PPR59030, PPR97306, PPS06907, PRINCEINF, R4211480, RO1224NM01, RU1018NM01, RU1021NM02, RU1085NM02, RU1091NM01, RU1095NM02, RU1152NM02, RU1212NM01, RU1284NM01, RU1294NM01, RU1302NM01, RU2050NM01, RU2199NM01, RU2311NM01, RU2311NM02, RU2526NM01, RU2527NM02, RU2527NM03, RU3143NM02, RU3314NM01, RU3424NM01, RU3448NM01, RU3508NM01, S4160059, S4160079, SA1001MN01, SA2146NM01, SLGHINF, TN1366NM01, UC4109NU02, UC7655NU03, UC7655NU04, UE282633, UE282648, UE720407, UEW19003, UEW19005, UK1110NM01, UK5002NM01, UP285A41, UPW00402, V1471114, V2147210, V2728105, V2728109, V2943412, V2943415, V4198004, V6414104, V7405209, V7406615, V7406617, V8572204, VASINF, VCWESTINF, VVMCINF1, X100611101, X105967809, X105967813, X119197203, X151957601, X2034002, X4211026, X59007307, X61014001, Y004NU08, Y004NU11, YE364413, YE364417, YE626937, YN1196, YN1200, YN1539, YN1540, YN1541, YN1542, YN1543, YN1544, YN1545, YN1546, YN1547, YN1548, YN1549, YN1550, YN1551, YN1552, YN1553, YN1554, YN1555, YN1556, YN1557, YN1558, YN1559, YN1560, YN1561, YN1562, YN1563, YN1564, YN1565, YN1566, YN1567, YN1568, YN1569, YN1570, YN1571, YN1572, YN1573, YN1574, YN1575, YN1577, YN1578, YN1579, YN1580, YN1581, YN1582, YN1583, YN1584, YN1585, YN1586, YN1587, YN1588, YN1589, YN1590, YN1591, YN1592, YN1593, YN1594, YN1595, YN1596, YN1597, YN1598, YN1599, YN1600, YN1601, YN1641, YN1650, YN1730, YN1742, YN1743, YN1744, YN1745, YN1760, YN1802, YN4218, YN4219, YN4220, YN4221, YN4222, YN4223, YN4224, YN4225, YN4226, YN4227, YN4228, YN4229, YN4230, YN4231, YN4232, YN4233, YN4234, YN4235, YN4236, YN4237, YN4238, YN4239, YN4240, YN4241, YN4242, YN4243, YN4244, YN4245, YN4248, YN4249, YN4250, YN4251, YN4252, YN4253, YN4254, YN4255, YN4256, YN4257, YN4258, YN4259, YN4260, YN4261, YN4262, YN4263, YN4264, YN4265, YN4266, YN4267, YN4270, YN4280, YN4288, YN4300, YN4312, YN4818, YN4819, YN4820, YN4821, YN4822, YN4824, YN4825, YN4830, YN4833, YN4900, YN4918, YN4919, YN4920, YN4921, YN4922, YN4923, YN4924, YN4925, YN4926, YN4927, YN4928, YN4929, YN4930, YN4931, YN4932, YN4933, YN4934, YN4935, YN4936, YN4937, YN4938, YN4939, YN4941, YN4942, YN4943, YN4944, YN4945, YN4946, YN4947, YN4948, YN4949, YN4950, YN4951, YN4952, YN4953, YN4954, YN4955, YN4990, YN4992, YN4999, YN5000, YN8001, YN8002, YN8003, Z001NU06, ZA1806NM12, ZA1807NM11, ZA1808NM13, ZA1820NM04, ZA1835NM24, ZA1835NM25, ZA2006NM04, ZA2008NM04, ZA2212NM02, ZA2246NM01, ZA2261NM01, ZTP0133, ZWL0437.

Distribution pattern

Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.

device · product 2 of 7

GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is 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 typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.

Z-1788-2013
Recall number
Z-1788-2013
Initiated
June 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
571

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.

Code information

System ID: 2998, 6970, 12865, 21414, 38070, 53263, 55461, 56948, 58230, 58378, 58379, 58483, 58510, 58582, 58622, 58630, 58711, 58785, 58797, 58808, 58810, 58871, 58883, 58919, 58958, 58993, 59012, 61061, 63422, 66515, 75074, 79722, 79966, 84636, 92635, 99691, 0850260033, 0850260034, 0850260035, 0850260038, 0850260040, 0850260041, 0850260042, 0850260046, 0850260048, 0850260054, 0850260057, 0850260062, 0853940029, 0853940068, 0853940069, 0853940077, 0853940078, 0853940080, 0853940082, 0856260014, 0856260019, 0910265011, 0910453006, 082426010009, 082426010010, 082426010011, 082426020002, 082426030009, 082426030010, 082426030015, 082426030016, 082426030018, 082426040016, 082426040020, 082426040021, 082426040024, 082426040025, 082426040026, 082426040029, 082426050001, 082426050002, 082426050003, 082426070014, 082426070015, 082426070016, 082426080006, 082426080007, 082426080009, 082426090013, 082426100017, 082426100019, 082426100020, 082426100023, 082426110002, 082426120003, 082426120004, 082426130012, 082426130013, 082426130014, 082426130015, 082426130016, 082426130019, 082426140005, 082426140007, 082426140008, 082426140009, 082426140011, 082426140012, 082426150003, 082426150006, 082426160012, 082426160014, 082426160016, 082426160017, 082426160019, 082426160020, 082426160022, 082426160023, 082426180003, 082426190008, 082426190010, 082426200002, 082426210002, 082426210003, 082426210010, 082426220006, 082426230008, 082426230010, 082426250002, 082426280001, 082426290004, 082426310005, 082426310007, 082426310008, 08302603017002, 08302603135243, 08302606123002, 08302621006334, 083026031062021, 083026242100654, 083026590040004, 083026590040010, 083026598000594, 083026826753913, 0382E00013, 00023NUC06, 0009D, 00132NUC02, 00216NUC09, 00243NUC11, 00243NUC15, 00243NUC17, 00269NUC07, 00323NUC02, 00357NUC02, 00555NUC01, 00584NUC01, 00584NUC04, 0112B, 0277A, 030010NU02, 030028NU01, 030036NU06, 030082NU10, 030151NU05, 030220NU02, 030355NU02, 030388NU01, 0306A, 0343A, 0360A, 06007NUC16, 080041NU01, 082426040029P, 082426050001P, 082426140005P, 0850EL0011, 0850EL0012, 10433NUC01, 110012NU02, 110965NU05, 130083NU07, 13228MILLEN, 16003NUC03, 160070NU01, 190226NU17, 190282NU04, 203694MIL, 203852VG, 203932VG, 204837VG, 205823NMVG, 205933VH, 206288VG, 206598VG, 207795VH, 208529VG, 209334LNVG1, 209526MILVG, 212562VG, 215893VG, 220166NU01, 223410MILVG, 225763MVG, 228818MILLVG, 248828H, 248828VG, 248937VG, 256235OPNM1, 262785VG, 2894872VG2, 2894872VG3, 301896VG, 304256VG, 304487VG, 309662SJVG, 310231VGH1, 310289VG1, 312864VG, 313299VG, 334794MILVG, 361575VG, 402449SJVG, 404605PVGH, 404712VG, 406782SNM, 407277FVG2, 407896FVG1, 407933KVG, 408947VG, 409291HVG, 410605NM1, 410955VG1, 410955VH, 412359VG, 413781VG1, 413781VG2, 414219VG, 414328VG, 414384VG, 414447VG, 414544HEYE, 414544VG, 414777MIL, 414777VG2, 414961VG, 416284VG, 416284VG2, 416290VG, 416444VG, 416469DVH, 416534VG1, 416534VG2, 416586VG, 416656VG, 416747VARICAM, 416747VG, 416756VG, 418404NU01, 418862VARICAM, 419383VG, 440329VG, 443643VG, 450359VG1, 450359VG2, 480981NM1, 501686VG, 508997VG, 509575PYVGH, 510486VG1, 512753VG, 514495VG, 515263LVG, 516256VG, 518271SVG, 519421VG, 520757NM1, 530529VG, 540186NU01, 540596N3, 540953VG, 541276AVG, 559688NM1, 570791HAWK, 580355VGACQ, 589907MVG, 600062NM01, 601426VG, 602406VG, 602870NM1, 605333HAWKEYE, 608263VG, 608364VG, 609267VG, 610954VG, 613548VG, 613548VG2, 615322NM2, 615791VG, 630801VG, 70050NUC06, 705324VG, 705327VARICAM, 705743VG, 706845VG, 707554VG, 708422MIL, 708783VG, 714774VG, 715361VG, 716694VG, 716859VG, 717657VG, 718759VG, 718780GENIEVG, 718780VG, 73240-1, 781278VG, 781744VG2, 781744VH, 786090NU03, 787782VARICAM-1, 804281VG1, 807343BMILLVG, 807343CMILLVG, 809758VARICAM, 812537VG, 813725VG, 813788VG, 815842SJVG, 819563CVG, 819822VG, 828212VG, 828213VG, 843792NUCH, 845437VG, 847695MILMVG, 847842VG, 860343VGOPC, 860344VG, 863494VG, 864573MBVG1, 904202VG, 905472VG, 905527HAWKEYE, 905683VG, 905684VG, 905684VG2, 905845VG, 905848VG, 905855VG, 905883VG, 905895VG, 912691SCVG, 914734VG, 919684VG1, 920459VG, 920729VG, 920887VG, 949760VG1, 956632MVG, 956687HKI, 970491VG1, 973754VG, 978466VG, 978741VG, 979764VGH1, 989269VG, A004NU10, A2846901, A5103321, A5107736, A5111021, A5114718, A5116033, A5128734, A5129932, A5132115, A5177338, A5177340, A5177344, A5177347, A5188524, A5215912, A5236208, A5306504, A5333009, A5353816, A5632411, AH0101NM02, AH0101NM03, AH3701NM04, AH4307NM04, AH4660NM05, ALK0130, ALK0131, APL0236, B4155407, B5119109, B5131812, B5315325, B5365411, B5483426, C5123638, CC0618NU13, CY1088MN04, D007NU07, DE282013, DE619831, DEL26415, DHG0536, DK1026NM05, DLF0237, E001NU09, EE1020MN01, EEF51528, FE416038, FE816127, FEB52048, FHALTVGH1, FHORLVGH1, G001NU07, GEC21815, GEE34020, H1404NUC06, H2103NUC06, H5174NUC02, HBER01NU02, HC2250NU01, HC2250NU02, HC2250NU03, HC3314NU01, HC4387NU01, HC5036NU01, HJJT01NU02, HOR0250, HR4106NM01, HT2106NU02, HT2106NU05, ID9320, IL1020NM01, IL1028NM03, IL1028NM13, IL1059NM01, IL1061NM01, IL1061NM05, IL1062NM01, IL1066NM03, IL1067NM03, IL1072NM01, JHOCVG10464, M001NU10, M001NU14, M2846904, M2881704, M4024091, M4134620, M4143939, M4144609, M4144845, M4145121, M4160707, M4164912, M4211044, M5400305, M5460632, MAYO1VG4, MAYO1VGH1, MAYO4VG3, MC6946NU02, ME260802, ME504345, ME612431, MPX24714, NM10374, NM73049, NM73050, NM81394, NO1012MN04, NO1015MN03, NO1016MN27, PC0173NU06, PC0396NU03, PC2306NU01, PC4178NU01, PER02544, PER10924, PER10925, PL1003NM01, PL1008NM01, PL1143NM01, PMR12503, PPR12206, RADNETNM1724, RU1100NM01, RU1457NM01, RU1591NM01, SK1071NM01, SK1082NM01, U001NU12, UC1129NU01, UC1769NU07, UC4092NU01, UC4109NU01, WH231NM1, YE645816, YE645817, YN0438, YN0440, YN0444, YN0448, YN0450, YN0454, YN0455, YN0468, YN0475, YN0477, YN0479, YN0482, YN0486, YN0493, YN0498, YN0502, YN0506, YN0542, YN0543, YN0544, YN0638, YN0639, YN0640, YN0641, YN0642, YN0643, YN0844, YN0845, YN0846, YN0847, YN0848, YN0849, YN0850, YN0851, YN0852, YN0853, YN0854, YN0907, YN0909, YN0910, YN0911, YN0912, YN0913, YN0914, YN0915, YN0917, YN0918, YN0919, YN0920, YN0921, YN0922, YN0923, YN0924, YN0966, YN0979, YN0980, YN0981, YN0982, YN0983, YN0984, YN0985, YN0986, YN0987, YN0988, YN1000, YN1009, ZA1807NM08, ZWL0431,

Distribution pattern

Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.

device · product 3 of 7

Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is 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 typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.

Z-1789-2013
Recall number
Z-1789-2013
Initiated
June 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
50

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.

Code information

System ID: 57503, 57584, 57588, 57711, 57727, 57734, 57815, 57873, 58826, 0828960002, 082426010006, 082426130005, 082426160008, 00243NUC09, 0090J, 0177A, 0201B, 0252A, 0272B, 0274B, 0279A, 0280A, 0286A, 030038NU04, 030151NU02, 030232NU04, 080019NU03, 210001NU01, 250565NUC2, 416586HELIX, 418589HELIX, 506739HELIX, 519464HELIX, 61420HELIX, A5110123, A5153605, AP2302NM01, B4213128, B5315316, CS1013NM01, FE8161EL18, IL1041NM01, IL1042NM02, IL1062NM02, M4148612, M4392002, MPX247EL09, NE4191EL15, PL1139NM01, SK1042NM01.

Distribution pattern

Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.

device · product 4 of 7

Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories.

Z-1790-2013
Recall number
Z-1790-2013
Initiated
June 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
13

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re

Code information

System ID: 030151NU17, 387171NU01, 405456NM615, 406222LN615, 478272NM, 702304NM615, A5635609, HC0541NU03, HC3366NU02, NM24011, NM24015, ZA1819NM04, ZA2446NM01.

Distribution pattern

Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.

device · product 5 of 7

Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield 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 imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/ multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.

Z-1791-2013
Recall number
Z-1791-2013
Initiated
June 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
108

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re

Code information

System ID: 0850260134, 083026001113611, 00001NUC11, 00052NUC11, 030029NU05, 030151NU15, 030359NU07, 201418D630, 205333D630, 207664NM630, 208455NM630, 217544PH630, 251639D630, 262574D630, 269945D630, 270417D630, 281540D630, 301877D630, 305596D630A, 305596D630B, 317887D630, 318448D630, 318798D630, 319364D630A, 319364D630B, 330386D630, 334287NM630, 34363NUC01, 407431NU01, 409212NM630, 417533D630, 417781D630, 469814NM630, 580531NM630, 585922NM630, 601288D630, 601354D630, 601798D630, 609978D630, 614NCH630, 618443DISC1, 618842DISC1, 618942NM630, 619474D630, 651DSC630, 702388VNM2, 704355D630, 708684D630, 716372NM630, 719587D630, 770751D630, 773282D630, 801714D630, 804675D630A, 808485NM630, 813558D630, 813615D630, 814623D630, 815564D630, 816234D630, 843347D630, 843797TD630, 845454D630, 870939NU01, 870939NU02, 901226D630, 903GSD630, 904276DSC1, 904321DSC1, 905684D630, 913345D630, 918502DIS1, 936NMD630, 937SNHC630, 941LWRNM630, 956523D630, 978354DSV630, 989227D630, A5131865, A5366307, A5384208, A5812287, EG1040NM01, H002NU03, H3001NUC01, HC0863NU02, IE1018MN03, IE1044NM01, JHDSV630NM, M4216453, M4476428, M45052111, NM22073, NO1035MN06, NT3001, NT3002, NT3003, NT3010, NT3020, O009NU09, OSC630, PC3003NU01, PMAB01NU04, POIN630, PRINCE630, RTD0739, RU1136NM01, TP0004NU01.

Distribution pattern

Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.

device · product 6 of 7

Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.

Z-1792-2013
Recall number
Z-1792-2013
Initiated
June 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
213

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re

Code information

System ID: 0828260021, 0828260022, 0850260118, 0850260122, 0850260128, 0850260131, 0850260132, 0853260094, 0853260099, 0856260033, 0856260034, 0856260035, 0910262297, 0910262304, 0910262310, 0910262319, 0910262322, 0910262325, 0910262344, 0910263223, 0910263228, 0910263231, 0910263235, 0910263239, 0910263241, 0910263243, 0910263250, 0910264135, 0910264141, 0910264147, 0910265074, 0910265075, 0910265076, 0920269097, 082426040043, 082426040044, 082426060005, 082426070028, 082426070030, 082426080020, 082426090029, 082426090030, 082426130029, 082426130030, 082426150026, 082426160042, 082426210020, 082426230020, 083026009408410, 083026023683711, 083026201006810, 00001NUC12, 00028NUC01, 00042NUC02, 00046NUC06, 00065NUC08, 00123NUC01, 00149NUC01, 00149NUC03, 00197NUC14, 00199NUC13, 00200NUC07, 00200NUC08, 00234NUC09, 00361NUC08, 00432NUC02, 010120NU19, 030037NU08, 030082NU13, 030133NU13, 030360NU01, 05462NUC05, 06007NUC19, 080041NU04, 100032NU05, 10497NUC20, 110017NU06, 110022NU05, 11018NUC08, 190052NU09, 190163NU04, 190163NU06, 204726D670NM, 210060NU02, 212639NMD670, 250370D670, 260010NU06, 262574D670, 305674D670, 309671SPECT, 403343D670, 403943D670, 403943D670B, 404686NMCT, 410955D670, 410D6701, 415353D670, 416495D670, 418549D670A, 418549D670B, 423495D670, 514281D670, 514338D670, 514842AD670, 514848D670, 514876D670, 519973D670, 529150NU05, 540332D670, 600092NM11, 610402D670NM1, 613548D670, 614NCH670, 615322NM5, 615893MMCT1, 617638DSV670, 630432D670, 720848D670, 803751D670, 819563D670, 819563D670B, 856247D670, 856247NM, 900010NU09, 905472D670, 905684D670A, 905684D670B, 905883D670, 972747NM670, 972935D670, A4169312, A4194844, A51051127, A51142126, A5125139, A5129983, A5196344, B4182011, B5140618, BG4009NM01, D007NU12, DK1029NU14, DK1047NM01, EE1020NM03, FE416061, FI1052MN01, GP1000NM01, HOR0281, IL1020NM36, IL1041NM30, IL1062NM29, M001NU42, M2002713, M251400603, M4134637, M4143630, M4143993, M4144126, M4145158, M4194042, M4198090, M4210246, M4215577, M4476424, M4505290, M5172553, M5400562, M5480777, M9409545, M9886847, MEX68915, NO1018MN06, NO1087MN09, NO1088MN16, NT1001, NT1002, NT1003, NT1004, NT1005, NT1006, NT1007, NT1008, NT1009, NT1010, NT1011, NT1013, NT1015, NT1020, NT2001, NT2002, O005NU27, PC8262NU01, PITT670, RTD0737, RU1095NM03, RU1279NM02, RU1949NM01, RU3451NM01, RU3467NM01, RU3623NM01, RU3637PT01, RU3713NM01, RU3900NM01, RU6340NM01, RU7175NM01, RU7187NM01, RU7505NM01, UX2305NU01, V4144610, V4169306, X102874005, X4144501, XM203402.

Distribution pattern

Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.

device · product 7 of 7

Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies

Z-1793-2013
Recall number
Z-1793-2013
Initiated
June 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re

Code information

System ID: 0910263253, 0910263256, 00139NUC08, 00162NUC11, 030232NU15, 215728OPT640, 262574O640, 270956NM640, 410543NUC640, 715735OPT1, 717782640NM, 808485NM640, 815564O640, 816234D640, 817250NM640, 847872O640, 901516GO640, 915839NU01, 928214NMCT, A5366308, A5639613, BD003NU01, DK1054NM03, RTD0782, XM203401.

Distribution pattern

Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.