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

Class I - Dangerous

🏥 Medical Devices Recalled: December 23, 2015 GE Medical Systems Diagnostic Equipment

What Should You Do?

Check if you have this product:
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.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: GE Medical Systems, LLC
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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, 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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, 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Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0770-2016

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