Exact FDA event identifier

Event 72974

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

Event summary

Timeline bucket: December 23, 2015
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: GE Medical Systems, 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

3 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 3

GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.

Z-0768-2016

Recall number: Z-0768-2016
Initiated: December 23, 2015
Classification: Class II
Status: Terminated
Recalling firm: GE Medical Systems, LLC
Quantity: 2389

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.

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

Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.

Code information

Lot or Serial numbers including but not limited to: 00001033715WK2, 12535HL3, 00000078321HL7, 00000096815HL6, 00000081147HL1, 00001032621WK3, 00000092076HL9, 00000092382HL1, 00000460115GE9, 00000079932HL0, D3s14793, 00000088642HL4, 116635HL4, 120632HL5, GEGR2411, GEGR5073, 00001027151WK8, 00000129105HL3, 261417HP0, 261416HP2, 1035189WK8, 00000084720HL2, 00000087109HL5, 00000100735HL0, 121206HL7, 125007HL5, 125019HL0, 1028231WK7, 00000126237HL7, 00000102072HL6, 00000092394HL6, 00000115802HL1, 124167HL8, 00001033721WK0, 00000108520HL8, 00000087928HL8, 00000111794HL4, 00000110657HL4, 00000092629HL5, 119090HL9, 00000442129GE3, 00000128179HL9, 00000110710HL1, 83621HL3, 00000082207HL2, 1034762WK3, 00000081499HL6, 00000088705HL9, 00000085601HL3, 00001031247WK8, 00000084721HL0, 00000084410HL0, 00000086179HL9, 1033866WK3, 00000084286HL4, 00000096817HL2, 00000092948HL9, 00000106841HL0, 00000105475HL8, 00001033220WK3, 00000106072HL2, 00000110662HL4, 00000106055HL7, 00000008789HL5, 00000084415HL9, 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00000122207HL4, 121194HL5, 00000115792HL4, 00000110114HL6, 00000108567HL9, 00000101080HL0, 00000098218HL1, 120157HL3, 141971BT2, 141763BT3, 00000110108HL8, 00000091396HL2, 00001033526WK3, 1030927WK6, 1036188K9, 00000123720HL5, 00000125009HL1, 00000085057HL8, 00001033598WK2, 00001033497WK7, 00000108568HL7, 110716HL8, 00000099199HL2, 00001031707WK1, 00000102070HL0, 00001033846WK5, 00001033860WK6, 00001033848WK1, 00001033812WK7, 00001033847WK3, 00000079930HL4, 00000115772HL6, 00000115786HL6, 00000114090HL4, 00000115793HL2, 00000116628HL9, 00000115789HL0, 00000115230HL5, GEGR3672, XA44939-8, 00000451441GE0, 81164HL6, GEGR4159, 00000125694HL0, 00000126226HL0, 00000098199HL3, 00000098208HL2, 122228HL0, UA45964-6, 1035064WK3, 00000096586HL3, 124173HL6, 124171HL0, 00000124173HL6, 114186HL0, 00000117188HL3, 00000126243HL5, 00000126925HL7, 00000124477HL1, 1865992, 00001033632WK9, 00001033603WK0, 00000101974HL4, 103144204, 00000095896HL7, 00000081822HL9, 00000082741HL0, 00000095905HL6, 00000096809HL9, 00000104911HL3, 00000099185HL1, 00000101078HL4, 00000100196HL5, 00000099193HL5, 00000086013HL0, 112123HL5, 114145HL6, 114101HL9, 114154HL8, 112131HL8, 114142HL3, 1033859WK8, 00000112133HL4, 1033918WK2, 112116HL9, 114156HL3, 00000113142HL4, 00000117867HL2, 00000117871HL4, 117867HL2, 121110HL1, 120819HL8, 1034568WK4, 121111HL9, 117848HL2, 114169HL6, 00000112116HL9, 00001035031WK2, 00000119755HL7, 137314BT1, 00000102086HL6, 00000086379HL5, 1030513WK4, 1027371WK2, 00000084716HL0, 00001031750WK1, 00001031740WK2, 00001031751WK9, 00000109410HL1, 00000079558HL3, 00000397886GE3, 00000084730HL1, 00000100729HL3, 00000080872HL5, 00000086839HL8, 00000089864HL3, 00000090232HL0, 00000076835-Y3, 00000126942HL2, 00000126940HL6, 00000127661HL7, 00000120166HL4, 00000085906HL6, 101157HL6, GEGR1866, GEGR3350, 00001031034WK0, 00001031065WK4, 00001028080WK8, 00001028078WK2, 121176HL2, 00000122013HL6, 00000122247HL0, 1035461WK1, 119754HL0, 00000082244HL5, 00000076476HL1, 00001032808WK6, 00000104582HL2, 00000100425HL8, 00000128378HL7, 00001030587WK8, 00000084182HL5, 123723HL9, 12504HL1, 00000123723HL9, 00000081167HL9, 00000087895HL9, 00000084152HL8, 00000088765HL3, 00000101074HL3, 00001034049WK5, 00000077914HL0, 127655HL9, 00000080691HL9, 00001027506WK3, 00000107455HL8, 00000112089HL8, 125017HL4, 125105BT7, 00000104897HL4, 00000102079HL1, 00000101303HL6, 00000104585HL5, 121107HL7, 00000122025HL0, 00000459936GE1, 00000085911HL6, 00000115795HL7, 00000087086HL5, 00000105785HL0, 00000105474HL1, 119088HL3, 00000078320HL9, 00000085033HL9, 00000096581HL4, 00000126935HL6, 00000127205HL3, 00000081170HL3, 00000101076HL8, 00000079634HL2, 00000079919HL7, 00000080631HL5, 00000078976HL8, 00000101699HL7, XA44935-4, 00001031167WK8, 00000099194HL3, 00000098609HL1, 00000098200HL9, 00000077779HL7, 00001036814WK0, 00000104501HL2, 00000117849HL0, 000001033991WK9, 1029974WK1, 00000096600HL2, 00000095910HL6, 00000124191HL8, 00000125350HL9, GEGR3804, GEGR3133, GEGR3144, 00001031572WK9, 00000110107HL0, GEGR4593, 00000106838HL6, 114190HL2, 115764HL3, GEGR2559, GEGR3991, 00000081820HL3, GEGR4004, 00000079109HL5, 1027505WK5, 00000079274HL7, 00000108532HL3, 00000104578HL0, 00000100171HL8, 00000100742HL6, 00000084404HL3, 00000115491HL3, 00000115494HL7, 00000122921HL0, 00000100420HL9, 00000087765HL4, 1029046wk8, 120164HL9, 00000105464HL2, 00000084911HL7, 00000085052HL9, 00000095908HL0, 00001031208WK0, 00001031178WK5, 00000103621HL9, 00000118276HL5, 00000118468HL8, 1035210WK2, 00000081689HL2, 00000089141HL6, 00000089150HL7, 117202HL2, 00000084401HL9, 00000085051HL1, 00000087855HL3, 00000100737HL6, 000000GEGR2552, 00000118556HL0, 1033944WK8, 1034140WK2, 118682HL4, 00000105802HL3, 00000105463HL4, 00000122261HL1, 00000106049HL0, 00000127658HL3, 00000104944HL4, 00000112105HL2, 00000100183HL3, 00000079920HL5, 00000079926HL2, 00000118465HL4, 00000088643HL2, 00000117877HL1, 00000118272HL4, 00000082476HL3, 00000115486HL3, 00000087068HL3, 00000091752HL6, 00000117859HL9, 00000116664HL4, 00000086995HL8, 00000087931HL2, 00000085049HL5, 00000086175HL7, 00000084111HL4, 114184HL5, 120817HL2, 00000083003HL4, 00000105462HL6, 00000079111HL1, 00000112109HL4, 00000083603HL1, 00000084151HL0, 00000084171HL8, 00000081694HL2, 00001029933WK7, 00000079560HL9, 00000087919HL7, 00000108116HL5, 00000096596HL2, 00000325458GE8, 00001030241WK2, 00000095355HL4, 00000097743HL9, 00000097759HL5, 00000081818HL7, 00000097753HL8, 00001027880WK2, 00001030029WK1, 00000098635HL6, 00000002797EN9, 00000002799EN5, 00000002798EN7, 00000002796EN1, 00000080688HL5, 00001027351WK4, 00000084270BT8, 00000082570BT3, GEGR3740, 00000098203HL3, 00000088763HL8, 00000101694HL8, 00000076788HL9, 109407hl7, 00001034056WK0, 00001033894WK5, 00001032408WK5, 00001029037WK7, 00000086363HL9, 00001028120WK2, 00000127681HL5, 00000121191HL1, 00000092627HL9, 00000082466HL4, 00000089491HL5, 00000087896HL7, 00000097751HL2, 00001036825WK6, 00001031032WK4, 00000104930HL3, 00000096595HL4, 00000100429HL0, 00000100419HL1, 00000100424HL1, 00000083616HL3, 00000082251HL0, 00000081488HL9, 00000098196HL9, 00001028218WK4, 00000081803HL9, 00000101975HL1, 00001028287WK9, 00000087914HL8, 00000082211HL4, 00000105793HL4, 00000090220HL5, 00000081494HL7, 00000088683HL8, 00000085660HL9, 00000120198HL7, 00000081163HL8, 00001033077WK7, 00001033080WK1, 00001034448WK9, 00000112149HL0, 00001035829WK9, 00001032573WK6, 00001032620WK5, 00001032663WK5, 00001032713WK8, 00001032714WK6, 00001032715WK3, 00001032766WK6, 00000081825HL2, 00000106061HL5, 00001033086WK8, 00001036454WK5, 00001033406WK8, 00001036471WK9, 00001031657WK8, 00001033144WK5, 00001033076WK9, 00000128424BT9, 00001034555WK1, 00001033779WK8, 115241HL2, 00000081691HL8, SH2014-0971, 00000078488HL4, 00000081692HL6, 00000087852HL0, 00000087854HL6, 450173GE0, 1027263WX1, 00001027061WK9, 122201HL7, 00000079929HL6, 00000080778HL4, 00000091755HL9, 00001031401WK1, 00000078318HL3, GEGR3979, 1034621WK1, 00000117431HL7, 00000117861HL5, 00000121190HL3, 00000122258HL7, 00000122259HL5, 122218HL1, 00000098622HL4, 106699HL2, 00000117194HL1, 00000100428HL2, 00000104910HL5, 00000087758HL9, 113167HL7, 00000088680HL4, 118290HL6, 118450HL6, 118681HL6, 120653HL1, 120646HL5, 00000112124HL3, 00000112129HL2, 115227HL1, 112129HL2, 114146HL4, 115228HL9, 114087HLO, 113111HL9, 113179HL6, 1034084WK2, 00000081485HL5, 10541HL8, 00000105461HL8, 00000080784HL2, 00000092396HL1, 00000100436HL5, 00000098634HL9, 00000084414HL2, 00000087907HL2, 0000092060HLK3, 00000086366HL2, 00000088764HL6, 00000088707HL5, 00000087900HL7, 00000136553BT5, 00001034133WK7, 00000119133HL7, 00000122918HL6, 00000124484HL7, 00000125024HL0, 00000404460GE8, 00000124199HL1, 00000117178HL4, 00000124202HL3, 00000120659HL8, 1036147WK5, 00000118674HL1, 00000113155HL6, 00000113162HL2, 00000117422HL6, 00000115783HL3, 00000120194HL6, 00000115505HL0, 00000115769HL2, 00000118463HL9, 1034134WK5, 1034153WK5, 00000118264HL1, 00000118263HL3, 00000118279HL9, 1036574WK0, 00000122928HL5, 00000079625HL0, 00000114176HL1, 00000111418HL0, 00000115503HL5, 00000116644HL6, 00001035434WK8, 00000124485HL4, 00000111925HL4, 00000122919HL4, 00000118549HL5, 00000128177HL3, 00000108562HL0, 00001034700WK3, 00000122903HL8, 00000120199HL5, 00000122935HL0, 00000117428HL3, 00000118548HL7, 00000118283HL1, 00000120196HL1, 00000122913HL7, 00000117416HL8, 00000137388BT5, 1036573WK2, 00001034636WK9, 00000107454HL1, 00001030160WK4, 00001034665WK8, 00001035314WK2, 00000087097HL2, 00000093369HL7, 00001030968WK0, 00000101070HL1, 00001035077WK5, 00001035117WK9, 00000118274HL0, 00000106687HL7, 00001031286WK6, 00001031337WK7, 00001028285WK3, 00001028536WK9, 00001028898WK3, 00000084921HL6, 00000087915HL5, 00000082734HL5, 00000080686HL9, 00000098179HL5, 00000100177HL5, 00000081881BT5, 00000083338HL7, 00000119757HL3, 00000098187HL8, 00000096577HL2, 00001030212WK3, 00000095352HL1, 00000081804HL7, 00000083605HL6, 00000084185HL8, 00000455959GE8, 00001030915WK1, 00000128182HL3, 00000127954HL6, 00000092944HL8, 00001029378WK5, 00001030845WK0, 00001030952WK4, 00001028286WK1, 00001033607WK1, 00000082208HL0, 00001027445WK4, 00000100169HL2, 00000098212HL4, 00001029675WK4, 00001029697WK8, 00001029069WK0, 00001029737WK2, 00001029696WK0, 00001028980WK9, 00001028979WK1, 00000089134HL1, 00000089860HL1, 00000090977HL0, 00000090972HL1, 00000086378HL7, 00000092388HL8, 00000116638HL8, 00000117866HL4, 00000077722BT7, 00000090976HL2, 00000081807HL0, 00000081808HL8, 00000360203GE4, 00000109098BT4, 00000149409BT5, 00000086992HL5, 00000104943HL6, 00000081795HL7, 00000082482HL1, 00000082735HL2, 00000082720HL4, 00000091399HL6, 00001031287WK4, 00001030796WK5, 00001030669WK4, 00000123729HL6, 00000120658HL0, 00000122011HL0, 00000124497HL9, 00000124197HL5, 00000120651HL5, 00000124196HL7, 00000123727HL0, 00000120197HL9, 0000000015B150, 0000000015B452, 00000122217HL3, 00000118275HL7, 00000121215HL8, 00000122944HL2, 00000082747HL7, 00000104579HL8, 00000098175HL3, 00001029861WK0, 00000117433HL3, 00000111423HL0, 00001033545WK3, 00000108583HL6, 00000123736HL1, 00000124504HL2, 00000123735HL3, 00000093378HL8, 00000124168HL6, 00000088759HL6, 00000120185HL4, 00000124995HL2, 00000096825HL5, 00000099172HL9, 00000089139HL0, 00000098198HL5, 00000091049HL7, 00000089135HL8, 00001035075WK9, 00001035119WK5, 00001035228WK4, 00001035181WK5, 00001035187WK2, 00000087858HL7, 00000087889HL2, 00000104511HL1, 00000105798HL3, 00001027149WK2, 00001027259WK9, 00000112136HL7, 101291HL3, 00000086178HL1, 85024HL8, D3S141095, 00001033075WK1, 00001029446WK0, 00001033091WK8, 00001031506WK7, 00001030286WK7, 00001032135WK4, 00001029054WK2, 00001033177WK5, 00001029373WK6, 00001029040WK1, 00001029163WK1, 00001029442WK9, 00001029595WK4, 00001029374WK4, 00001030801WK3, 00001030809WK6, 00001030810WK4, 00001030811WK2, 00001030840WK1, 00001030841WK9, 00001034761WK5, 00001034782WK1, 00001031119WK9, 00001031170WK2, 00001030284WK2, 00001031465WK6, 00001032574WK4, 00001029523WK6, 00001033661WK8, 00001028989WK0, 00001031571WK1, 00001031649WK5, 00001031652WK9, 00001031654WK5, 00001030562WK1, 00001032604WK9, 00001033038WK9, 00001029787WK7, 00001032681WK7, 00001032684WK1, 00001032682WK5, 00000108551HL3, 00000108552HL1, 00001031336WK9, 00001033079WK3, 00000082241HL1, 00000100191HL6, 00000098220HL7, 00001030842WK7, 00001029650WK7, 00001032493WK7, 00001032494WK5, 00001031011WK8, 00001034242WK6, 00000096821HL4, 00000077773HL0, 00000077254HL1, 00000090603HL2, 00001028066WK7, 00001034502WK3, 00001034384WK6, 00001034440WK6, 00000122231HL4, 00001033657WK6, 00000100188HL2, 00000112132HL6, 00000107447HL5, 00000083602HL3, 00000102087HL4, 00000100181HL7, 00000090234HL6, 00000085916HL5, 00000090607HL3, 00000116629HL7, 00000106053HL2, 00000089869HL2, 00000107157HLO, 00000359514GE7, 00001029701WK8, 00000117851HL6, 00000111415HL6, 00000110671HL5, 00000128415BT7, 00000102075HL9, 00000313283GE4, 00000104576HL4, 00000111421HL4, 00000104581HL4, 0000000014E825, 00000086845HL5, 00000077778HL9, 00000096819HL8, 00001033784WK8, 00000103013HL9, 00000101973HL6, 00000100180HL9, 00000103005HL5, 00000103623HL5, 00000103007HL1, 00000103003HL0, 00000103010HL5, 00000103788HL6, 00000102996HL6, 00000100738HL4, 00000099196HL8, 00000101073HL5, 00000097760HL3, 00000097752HL0, 00000084737HL6, 00000085910HL8, 00000084428HL2, 00001030926WK8, 00000087906HL4, 00000095382BT8, 00001029620WK0, 00000096808HL1, 00000096593HL9, 00000102076HL7, 00000103009HL7, 00000100182HL5, 00000103626HL8, 00000103008HL9, 00000102541HL0, 00000102546HL9, 00001032701WK3, 00000104919HL6, 00000104925HL3, 00000122256HL1, 00000121214HL1, 00000111796HL9, 00000113145HL7, 00001031391WK4, 00001030903WK7, 00001031386WK4, 00001033451WK4, 00001033432WK4, 00001033449WK8, 00001033450WK6, 00001029948WK5, 00000088706HL7, 00001031537WK2, 00001031515WK8, 00001033440WK7, 00001033176WK7, 00000085908HL2, 00000081498HL8, 00000086183HL1, 00000085654HL2, 00000085912HL4, 00000080877HL4, 00000096583HL0, 00000083600HL7, 00000096599HL6, 00000096814HL9, 00000105800HL7, 00000108564HL6, 00001031460WK7, 00001033023WK1, 00000085002HL4, 00001028347WK1, 00001028345WK5, 00001029743WK0, 00001028562WK5, 00000099198HL4, 00000106052HL4, 00000084916HL6, 00001034346WK5, 00000117191HL7, 00001030210WK7, 00001029951WK9, 00000086168HL2, 00000106073HL0, 00000086370HL4, 00000091422HL6, 00000087898HL3, 00000084726HL9, 00000110519HL6, 00000109439HL0, 00000110096HL5, 00000107452HL5, 00000097756HL1, 00000104922HL0, 00000084418HL3, 00000087104HL6, 00000085668HL2, 00000100305BT2, 00000112121HL9, 00000087920HL5, 00000082202HL3, 00000084998HL4, 00001030206WK5, 00001028852WK0, 00000107466HL5, 00000106840HL2, 00000107158HL8, 00000104921HL2, 00000105803HL1, 00000106697HL6, 00000106081HL3, 00000106069HL8, 00000102077HL5, 00000117193HL3, 00000081805HL4, 00000081800HL5, 00001030218WK0, 00000099177HL8, 00001033473WK8, 00001033495WK1, 00001033478WK7, 00001033477WK9, 00001032990WK2, 00001033476WK1, 00001033020WK7, 00001033491WK0, 00001033452WK2, 00001033474WK6, 00000085050HL3, 00000091429HL1, 00000087098HL0, 00001029685WK3, 00001028621WK9, 00001033439WK9, 00001033456WK3, 00001033457WK1, 00001033453WK0, 00001033464WK7, 00000108572HL9, 00000109428HL3, 00000119084HL2, 109393HL9, 1890073, 00000096584HL8, 00000107453HL3, 00000110697HL0, 00000110700HL2, 00000112083HL1, 00000110714HL3, 00000110673HL1, 00000112085HL6, 00000107162HL0, 00000109424HL2, 00000111926HL2, 00000109431HL7, 00000109408HL5, 00000111407HL3, 00000087762HL1, 00001030588WK6, 00000088648HL1, 00000113143HL2, 00000082467HL2, 00000121114HL3, 00001029677WK0, 00000081154HL7, 00001030209WK9, 00000122012HL8, 00000114173HL8, 00000UA46748-6, 00000UA46777-2, 00000UA46778-6, 00000115778HL3, 00000115801HL3, 83012HL5, 100179HL1, 98914HL5, 100198HL1, 100197HL3, 98910HL3, 00000098636HL4, 1033181WK7, 101697HL1, 88682HL0, 80632HL3, 1033021WK5, 81683HL5, 00001031519WK0, 00000110099HL9, 00000142358BT1, 00001035328WK2, 00000116641HL2, 00000117434HL1, 00000109409HL3, 00000117843HL3, 00000117880HL5, 00000117868HL0, 00000118544HL6, 00001035325WK8, 00000117844HL1, 00000117426HL7, 00000118270HL8, 00000114143HL1, 00000116657HL8, 00000120669HL7, 00000084114HL8, 00000081491HL3, 0000000014M659, 00001032305WK3, 00000078496HL7, 00000082235HL3, 00000078975HL0, 00000101304HL4, 00000087924HL7, 00000121116HL8, 00000120176HL3, 00000UA46931-1, 00000076791HL3, 00000106833HL7, 00000106071HL4, 00000106834HL5, 00000092612HL1, 00000084905HL9, 00000360306GE5, 00001029067WK4, 00001033660WK0, 00000085047HL9, 00000360249GE7, 00000075963HL9, 00000148583BT8, 00000084912HL5, 00000085046HL1, 00000088703HL4, 00000078312HL6, 00000115236HL2, 00000083007HL5, 00000084915HL8, 00000108556HL2, 00000106062HL3, 00000106698HL4, 00000112138HL3, 00000106051HL6, 00000119760HL7, 00000116646HL1, 00000122909HL5, 00001033864WK8, 00001033865WK5, 00000079275HL4, 00000107449HL1, 00000118286HL4, 00000117845HL8, 00000120671HL3, 00000121180HL4, 00000086997HL4, 00000UA46891-7, 00000115488HL9, 00000122254HL6, 00000102083HL3, 00000105479HLO, 00000113141HL6, 00001032320WK2, and 00000089483HL2.

Distribution pattern

Worldwide Distribution -- US, including Washington D.C. Puerto Rico, Virgin Islands, and Guam; and the countries of Afghanistan, Albania, Anguilla, Antigua and Barbuda, Armenia, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Lebanon, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Papua New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Trinidad , Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

device · product 2 of 3

GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.

Z-0769-2016

Recall number: Z-0769-2016
Initiated: December 23, 2015
Classification: Class II
Status: Terminated
Recalling firm: GE Medical Systems, LLC
Quantity: 126

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.

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

Code information

Lot or serial numbers include but not limited to: 00000086177HL3, 00001028564WK1, 115226HL3, 00000083538HL9, 00000092940HL6, 00000084909HL1, 00000081798HL1, 120634HL1, 00000084729HL3, 00000084161HL9, 00000082463HL1, 00000080868HL3, 120832HL1, 00000089868HL4, 00000082736HL0, 00000093379HL6, 00000092616HL2, 00000092633HL7, 00000081160HL4, 00000077253HL3, 00000076913HL3, 00000078498HL3, 00000084160HL1, 00000078315HL9, 00000082726HL1, 00000085039HL6, 00000080635HL6, 00000091403HL6, 00000085598HL1, 00000085661HL7, 00000077923HL1, 00000081481HL4, 00001027046WK0, 00000081152HL1, 00000086364HL7, 00000092622HL0, 00000085000HL8, 00000084999HL2, 00000084725HL1, 00000083029HL9, 00000078313HL4, 00000084162HL7, 00000083020HL8, 00000077471HL1, 00000083019HL0, 00000082738HL6, 00000083598HL3, 00000092618HL8, 00000084180HL9, 00000085594HL0, 00000084917HL4, 00000076790HL5, 00000091413HL5, 00001028931WK2, 00000102856WK4, 00001028927WK0, 00001028924WK7, 00000084159HL3, 00000084422HL5, 00001029525WK1, 00000077482HL8, 00000082250HL2, 00000075962HL1, 00000079632HL6, 00000082240HL3, 00000081484HL8, 00000084732HL7, 00000077924HL9, 00000079918HL9, 00000082247HL8, 00000082245HL2, 00000082243HL7, 00000077255HL8, 00000086373HL8, 00000087093HL1, 00000102539HL4, 00000085004HL0, 00000085599HL9, 00000079559HL1, 00000079282HL0, 00000077782HL1, 00000082480HL5, 00000079116HL0, 00001028894WK2, 00000078317HL5, 00000079280HL4, 00000129740WG7, 00000079278HL8, 00000078492HL6, 00000075947HL2, 00000084908KL3, 00000084412HL6, 00000084169HL2, 00001027692WK1, 00000085036HL2, 0000000012C559, 00000084178HL3, 00000093852HL2, 00000092058HL7, 00000087079HL0, 00001029020WK3, 00001028888WK4, 00001028659WK9, 00001028662WK3, 00001028661WK5, 00000086380HL3, 00001028660WK7, 00000084172HL6, 00001028595WK5, 00000086365HL4, 00000084411HL8, 00000084402HL7, 00000084906HL7, 00001028866WK0, 00001028925WK4, and 00000085034HL7.

Distribution pattern

device · product 3 of 3

GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.

Z-0770-2016

Recall number: Z-0770-2016
Initiated: December 23, 2015
Classification: Class II
Status: Terminated
Recalling firm: GE Medical Systems, LLC
Quantity: 895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.

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

Code information

Lot or serial numbers include, but not limited to: 00001031869WK9, 00001031925WK9, 00000081156HL2, GEGR2170, 00001033726WK9, 00000119120HL4, 00000084104HL9, 00001033405WK0, 00000085648HL4, 00001033548WK7, 1035415WK7, 124175HL1, 122205HL8, 1036207WK7, 00000086387HL8, 00000104902HL2, 00000087904HL9, 00000087902HL3, 00000106045HL8, 00000105791HL8, 00000083607HL2, 00000090594HL3, 00000090597HL6, 00001030061WK4, 00001030140WK6, 00001030142WK2, 114185HL2, 00001031534WK9, 00001031533WK1, 00001031696WK6, 00000092062HL9, 00001028273WK9, 00000106054HL0, 00000106067HL2, 00000105797HL5, 00000106074HL8, 00000105801HL5, 00000104928HL7, 00000093370HL5, 00000089482HL4, 00000085430HL7, 00000091765HL8, 120821HL4, 00000086171HL6, 00000089492HL3, 00000089863HL5, 00000104898HL2, 00000108421HL9, 00000092383HL9, 00000093388HL7, 00001032768WK2, 00000104929HL5, 00000104507HL9, 00000105458HL4, 00000090610HL7, 00000086388HL6, 00000083023HL2, 00000085899HL3, 00000080694HL3, 00000102536HLO, 00000092384HL7, 115224HL8, 00000090608HL1, 00000091221HL2, 00000087939HL5, 00000087912HL2, 00000086382HL9, 00000091420HL0, 00001031277WK5, 00000085023HL0, 00000100184HL1, 00000082246HL0, 00000089865HL0, 00001029027WK8, 00000108416HL9, 00001029021WK1, 00000117417HL6, 00000090227HL0, 00000090593HL5, 00000089495HL6, 00000087096HL4, 00000101153HL5, old-pos, 00000108581HL0, 00000110652HL5, 00000081168HL7, 00000107465HL7, GEGR4022, 1035828WK1, 00000108579HL4, 00000110665HL7, 00000098205HL8, 00000117423HL4, 00000086166HL6, 00000082242HL9, 427332GE2, 00001033782WK2, 119096hl6, 00000120673HL9, 00000083021HL6, 00000085425HL7, 00000086976HL8, 00000086973HL5, 00000094572BT5, 1035839WK8, 00000085428HL1, 120672HL1, 00000091392HL1, 00001028490WK9, 00000115766HL8, 00000118540HL4, 125111BT5, 00000115498HL8, 00000115243HL8, 00000117429HL1, 00000084397HL9, 00000092632HL9, ASTE-51009, 00000117424HL2, 436814GE8, 00000102543HL6, 00001030548WK0, 00000076405HL0, 00000081685HL0, 00000098618HL2, 00000099170HL3, 00000124188HL4, 00000120637HL4, 00000109390HL5, 00000082459HL9, 115234HL7, 121174HL7, 00000121174HL7, 00000095904HL9, 00000084417HL5, 00000084715HL2, 00000129117HL8, 00000079283HL8, 00000093377HL0, 00000087075HL8, 00000091398HL8, 00000077470HL3, 00000127206HL1, 00000127656HL7, 00000090970HL5, 00000106059HL9, 00000091417HL6, 00000082723HL8, 00000091391HL3, 00000115804HL7, 115804HL7, 00000121166HL3, 00000091395HL4, 00000091395-HL, 00000092613HL9, 00001033068WK6, 00001033184WK1, 00000224760HP9, 00000124012HL6, 00000083008HL3, 00000090611HL5, 124188HL4, 00000124172HL8, 00000085894HL4, 113140HL8, 00000099165HL3, 00000085061HL0, 00000103016HL2, 00000107468HL1, 00000092939HL8, 00000084920HL8, 00000082209HL8, 00000087913HL0, 00000084913HL3, 00000104588HL9, 00000110117HL9, 00000092386HL2, 00000103787HL8, 00000086372HL0, 00001033549WK5, 00000367990GE9, 00000224083HP6, 00000091430HL9, 00000105788HL4, 00000122010HL2, 00000083031HL5, 00000102081HL7, 00000103001HL4, 00000103624HL3, 00000084710HL3, 00000089497HL2, 00000111797HL7, 00000118470HL4, 00000089862HL7, 00000115239HL6, 00000091401HL0, 00000081812HL0, 00000090219HL7, 00000090600HL8, 00000085058HL6, 00000083025HL7, 00000103785HL2, 00000104899HL0, 00000093380HL4, 122030HL0, 124198HL3, 00000085900HL9, 00000089484HL0, 00000086391HL0, 00000077913HL2, 00000090216HL3, 00000085001HL6, 00000122237HL1, 00000090224HL7, 00000111923HL9, 00000127665HL8, 110713HL5, 122943HL4, 9102015, 00000109394HL7, 00000086385HL2, 00000085651HL8, 00000092074HL4, 00000081153HL9, 00000103017HL0, 00000106082HL1, 00000083594HL2, 00000085060HL2, 00000091431HL7, 00000081482HL2, GEGR4180, 00000084103HL1, 00000085038HL8, 00001028496WK6, 00000128722HL6, 126695HL6, 00000110102HL1, 1036298WK6, 00000117869HL8, 00000117879HL7, 1036347WK1, 00000083005HL9, 00000090596HL8, 00000079636HL7, 00001029965WK9, 00001029991WK5, 00000098216HL5, 00000085035HL4, 00000082472HL2, 00000083028HL1, 00000089499HL8, 00000098621HL6, 00001029907WK1, 00000090223HL9, 120204HL3, 00000085672HL4, 00000108111HL6, 124225HL4, 00000089867HL6, 00000090975HL4, 00000091400HL2, 00000102078HL3, 00000093375HL4, 00000083542HL1, 00000083535HL5, 00000087087HL3, 00000102535HL2, 00000083004HL2, 00000122257HL9, 00000126924HL0, 00000087910HL6, 00000242375HP4, 00000108521HL6, 00000112082HL3, 00000086371HL2, 00000090971HL3, 00000103006HL3, 125693hl2, 00000093386HL1, 00000090617HL2, 00000102548HL5, 00000093396HL0, 00000084717HL8, 00000092625HL3, 00000091764HL1, 00000091042HL2, 00000103002HL2, 00000077774HL8, 00000090601HL6, 00000090615HL6, 00000118288HL0, 00000091390HL5, 00000091751HL8, 00000092393HL8, 00001033037WK1, 00000126235HL1, 126240HL1, 00000083018HL2, 00000075960HL5, 00000104939HL4, 00000091388HL9, 00000078813HL3, 00000103791HL0, 00000085022HL2, 00000084149HL4, 00000092631HL1, 00000108112HL4, 00000105478HL2, 155565BT5, 00000124479HL7, 00000109399HL6, 00000092619HL6, 00000117420HL0, 00000118469HL6, 00001034445WK5, GEGR2374, 00000098981HL4, 00000106825HL3, 00000124483HL9, 00000090222HL1, 00000089870HL0, 00000087091HL5, 00000091426HL7, 00000085649HL2, 00000099169HL5, 00000108542HL2, 00000111406HL5, 113160HL6, 00000115245HL3, 00000129119HL4, 00000087916HL3, 00000089858HL5, 447838GE4, 126692HL3, 00001033676WK6, 121209HL1, 00000114102HL7, 00000110516HL2, 00000090602HL4, 00001033419WK1, 00000108115HL7, 00000115770HL0, 00000088767HL9, 00000090604HL0, 00000109414HL3, 00000102534HL5, 00000102540HL2, 00000087908HL0, 00001031809WK5, 00000102533HL7, 00000077481HL0, 00000100743HL4, 00000090598HL4, 00000098197HL7, 11111, 433352GE2, GEGR1161, 00000110115HL3, 00001033815WK0, 00001032543WK9, 142890BT3, 00000127669HL0, 00000086376HL1, 00000105466HL7, 124179HL3, 00001033552WK9, 00001033664WK2, 00000103620HL1, 00000087905HL6, 00000126700HL4, 00000110686HL3, 117857HL3, 00000123741HL1, GEGR3739, 00000102547HL7, 114157HL1, 113106HL9, 00000105395BT8, 00000099158HL8, 00000110647HL5, 00000127662HL5, 00000128717HL6, 00000129108HL7, 00000110711HL9, 00000098210HL8, 00000112080HL7, 00000077925HL6, 00000085041HL2, 143250BT9, 00000091404HL4, 00000086977HL6, 1032498WK6, 00000105483HL2, 00000110518HL8, 00000084425HL8, 00000121177HL0, 00000109405HL1, 00000082719HL6, 00000084431HL6, 00000129968BT4, 00001033375WK5, 00000090217HL1, 00000368036GE0, 00000088644HL0, 000000GEGR1831, 00001030910WK2, 00000107470HL7, 00001033118WK9, 00000103018HL8, 00000087917HL1, 00001035261WK5, 00001033783WK0, 00001034203WK8, 00000085643HL5, 00001029480WK9, 00000117870HL6, 00001033042WK1, 00000097748HL8, 00001033078WK5, 00001034960WK3, 00000082722HL0, 00000082481HL3, 00000081503HL5, 113158HL0, UA46929-7, 00000105465HL9, 00000085032HL1, 101081HL8, 00000090225HL4, 00000082470HL6, GEGR3975, 00000083013HL3, 00000081489HL7, 00000082724HL6, 00000083009HL1, 112117HL7, 00000082249HL4, 00000082473HL0, 432199GE8, 124174HL4, 00000090226HL2, 00000083620HL5, 00000084112HL2, 00000080780HL0, 00000087090HL7, 00000089494HL9, 00000091748HL4, 00000082478HL9, 00000081493HL9, 00000082479HL7, 00000083002HL6, 00000087067HL5, 86394HL4, 00000090218HL9, 00001031046WK4, 00000084399HL5, 00000113144HL0, 441284GE7, 00000075948HL0, 93847HL2, 00000077476HL0, 00000112114HL4, 000000GEGR3075, 00000092623HL8, 00000089487HL3, 00001029478WK3, 00001030966WK4, 00000099163HL8, 00000122236HL3, 00001035840WK6, 00001029898WK2, 00000087069HL1, 00000091746HL8, 00000093384HL6, 00001032380WK6, 00001032661WK9, 00000092063HL7, 00000117846HL6, 00000114155HL5, 00000126931HL5, 00000094216BT9, 00000121182HL0, 00000368089GE9, 00000112112HL8, 00000100421HL7, 00000118554HL5, 00000113164HL8, 00000122252HL0, 00000112144HL1, 00000112134HL2, 00001029448WK6, 00000091389HL7, 00000110090HL8, 00000087071HL7, 00000108557HL0, 00000108561HL2, 00000120657HL2, 00000117854HL0, 00000117208HL9, 00000116104BT1, 00000117180HL0, 00000124166HL0, 00000090973HL9, 00000103012HL1, 00000102542HL8, 000000GEGR1014, 00000090230HL4, 00000107462HL4, 00000120190HL4, 00000090233HL8, 00000089857HL7, 00000122908HL7, 00000367818GE2, 00000100749HL1, 00000076461HL3, 00001033939WK8, 00001030742WK9, 00001034715WK1, 00001034381WK2, 00001035412WK4, 00000344268GE8, 00001033916WK6, 00000092626HL1, 00000084903HL4, 00001030752WK8, 00000108121HL5, 00001035159WK1, 00001034204WK6, 00000124499HL5, 00000124498HL7, 00000089875HL9, 00000101696HL3, 00001034447WK1, 00000349207GE1, 00000101707HL8, 00000108578HL6, 00000085586HL6, 00000098221HL5, 00000115768HL4, 00000115765HL0, 00000115781HL7, 00000423355GE7, 00000125012HL5, 00000125018HL2, 00000125016HL6, 00000102537HL8, 00000114141HL5, 1036323WK2, 00000102532HL9, 00000104508HL7, 00001028494WK1, 00000115782HL5, 00001031399WK7, 00001031418WK5, 00001035241WK7, 00001035277WK1, 00001035593WK1, 00001031365WK8, 00001033143WK7, 00001028928WK8, 00001034961WK1, 00001030753WK6, 00001030817WK9, 00001030818WK7, 00001031764WK2, 00001028862WK9, 00001029023WK7, 00001030336WK0, 00001030363WK4, 00001035640WK0, 00001030937WK5, 00001031753WK5, 00001033101WK5, 00001029026WK0, 00001030297WK4, 00001035028WK8, 00001030547WK2, 00001032502WK5, 00001032346WK7, 00001032382WK2, 00001032383WK0, 00001033203WK9, 00001030298WK2, 00001031420WK1, 00001031050WK6, 00001031217WK1, 00001031695WK8, 00001027717WK6, 00001033117WK1, 00000109402HL8, 00000103014HL7, 00000095323HL2, 00000082461HL5, 00000097930HL2, 00000092942HL2, 00000092069HL4, 00000122008HL6, 00000092621HL2, 00001029996WK4, 00001029997WK2, 00001029998WK0, 00001029999WK8, 00001030158WK8, 00001030159WK6, 00001030161WK2, 00001030163WK8, 00001030164WK6, 00001030165WK3, 00001030166WK1, 0001030201WK6,, 00001028226WK7, 00001030623WK1, 00001030263WK6, 00000093372HL1, 00001032505WK8, 00000090231HL2, 00000095901HL5, 00000107461HL6, 00000111795HL1, 00000084157HL7, 00000115500HL1, 00000126225HL2, 00000111426HL3, 00000103015HL4, 00000113113HL5, 00000112126HL8, 00000126703HL8, 00000126230HL2, 00000126231HL0, 00000126232HL8, 00000112152HL4, 00000093385HL3, 00000122248HL8, 00000098614HL1, 00000110655HL8, 00000091050HL5, 00000126704HL6, 00000091405HL1, 00000093381HL2, 00000093382HL0, 00000101687HL2, 00000088760HL4, 00000087903HL1, 00000081806HL2, 00000108585HL1, 00000108584HL4, 00000106693HL5, 00000105476HL6, 00000105790HL0, 00000105787HL6, 00000106070HL6, 00000082236HL1, 00000086975HL0, 00000085667HL4, 00000100432HL4, 00000089486HL5, 00000077770HL6, 00000119116HL2, 00000085657HL5, 00000086847HL1, 00000108119HL9, 00000108528HL1, 00000084405HL0, 00000109417HL6, 00000082464HL9, 00000120649HL9, 00001035441WK3, 00000092398HL7, 00000092397HL9, 00000085037HL0, 00000081686HL8, 00000081157HL0, 00000099159HL6, 00000082732HL9, 00000102069HL2, 00000914006HL9, 00000116634HL7, 00000115775HL9, 00000116625HL5, 00000106692HL7, 00000086162HL5, 00000099166HL1, 00000126927HL3, 00001035264WK9, 00000100199HL9, 00000101299HL6, 00000104506HL1, 00000124178HL5, 00000104509HL5, 00000115238HL8, 00000120179HL7, 00000098906HL1, and 00001034958WK7.