GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
- Company
- Ge Medical Systems, Llc
- Recall Initiated
- December 23, 2015
- Posted
- February 8, 2016
- Terminated
- September 7, 2016
- Recall Number
- Z-0770-2016
- Quantity
- 895
- Firm Location
- Waukesha, WI
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.
Distribution
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.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
Consignees were sent on 12/23/2015 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 10906 dated December 18, 2015. The letter was addressed to Director of Biomedical Engineering, Director of Radiology and Chief of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers may continue to use the system. The firm will correct the affected devices and no charge to the customer; and a GE Healthcare representative will contact customers to arrange for the correction. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.