|
Class 2 Device Recall GE Healthcare Optima XR200amx |
|
Date Initiated by Firm |
December 23, 2015 |
Date Posted |
February 08, 2016 |
Recall Status1 |
Terminated 3 on September 07, 2016 |
Recall Number |
Z-0770-2016 |
Recall Event ID |
72974 |
510(K)Number |
K142383
|
Product Classification |
System, x-ray, mobile - Product Code IZL
|
Product |
GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System
Designed to generate diagnostic radiographic images. |
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. |
Recalling Firm/ Manufacturer |
GE Medical Systems, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
|
For Additional Information Contact |
800-437-1171
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = IZL and Original Applicant = GE Medical Systems, LLC
|
|
|
|