510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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Z-0770-2016Class II

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

GE Healthcare / initiated 2015-12-23 / Terminated / root cause: design
FDA source (opens on fda.gov)

GE Medical Systems, LLC began a recall of GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0770-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
Product
GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Product code
IZL System, X-Ray, Mobile
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.
Root cause tag
design
FDA root cause
Device Design
Action
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.
Quantity in commerce
895
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.
Product codes and lots
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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0770-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0768-2016Class IITerminatedVoluntary: Firm initiated
Z-0769-2016Class IITerminatedVoluntary: Firm initiated
Z-0770-2016Class IITerminatedVoluntary: Firm initiated