Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision…

Date

Jan. 29, 2014

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII Product Usage: The systems are intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations on both adult and pediatric subjects. The systmes are used for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Reason

Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the system. GE is not aware of any fall of the overhead monitor suspension.

Distribution pattern

Worldwide Distribution - US Nationwide including Washington D.C., Guam, and Puerto Rico. Outside the US to include: Afghanistan, Algeria, Argentina, Australia, Austria, Azerbaijan, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina faso, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Lebanon, Libyan Arab Jamahiriya, Macedonia, Malaysia, Mali, Malta, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Niger, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yemen.

Quantity

5651

Codes and lots

serial numbers: 182, 00000000159728, 719723, 00000000045GP5, 00000000047GP1, 00000000120GP6, 00000000167GP7, 00000000168GP5, 00000000169GP3, 00000000170GP1, 00000000171GP9, 00000000175GP0, 00000000177GP6, 00000000180GP0, 00000000182GP6, 00000000184GP2, 00000000185GP9, 00000000186GP7, 00000000190GP9, 00000000223GQ8, 00000000252GP7, 00000000254GP3, 00000000256GP8, 00000000259GP2, 00000000277GQ4, 00000000331GP9, 00000000334GP3, 00000000353GP3, 00000000379GP8, 00000000380GP6, 00000000381GP4, 00000000382GP2, 00000000438GP2, 00000000439GP0, 00000000440GP8, 00000000444GP0, 00000000490GP3, 00000000491GP1, 00000000506GP6, 00000000556GP1, 00000000558GP7, 00000000590GP0, 00000000591GP8, 00000000592GP6, 00000000593GP4, 00000000594GP2, 00000000669GQ2,, 00000000694GP0, 00000000695GP7, 00000000701GP3, 00000000708GP8, 00000000778GP1, 00000000817GP7, 00000000818GP5, 00000000848GP2, 00000000884GP7, 00000000885GP4, 00000000917GP5, 00000000920GP9, 00000000921GP7, 00000000922GP5, 00000000923GP3, 00000000924GP1, 00000000946GP4, 00000000963GP9, 00000000964GP7, 00000000965GP4, 00000000AD6037, 00000000AD7002, 00000000AI6036, 00000001032GP2, 00000001033GP0, 00000001034GP8, 00000001035GP5, 00000001046GP2, 00000001067GP8, 00000001088GP4, 00000001091GP8, 00000001098GP3, 00000001106GP4, 00000001107GP2, 00000001109GP8, 00000001111GP4, 00000001232GP8, 00000001233GP6, 00000001267GQ4, 00000001341GP7, 00000001367GP2, 00000001374GP8, 00000001380M35, 00000001425GP8, 00000001433GP2, 00000001434GP0, 00000001435GP7, 00000001438GP1, 00000001441GP5, 00000001442GP3, 00000001453GP0, 00000001483GP7, 00000001540GP4, 00000001541GP2, 00000001543GP8, 00000001612GP1, 00000001614GP7, 00000001615GP4, 00000001663GP4, 00000001665GP9, 00000001737GP6, 00000001803M36, 00000001835GP8, 00000001848GP1, 00000001867GP1, 00000001868GP9, 00000001881M32, 00000001894GP5, 00000001895GP2, 00000001896GP0, 00000001897GP8, 00000001898GP6, 00000001942GP2, 00000001943GP0, 00000001944GP8, 00000001946GP3, 00000001971M31, 00000001991GP9, 00000001998GP4, 00000001999GP2, 00000002000GP8, 00000002115GP4, 00000002117GP0, 00000002194GP9, 00000002197GP2, 00000002198GP0, 00000002316GP8, 00000002319M32, 00000002337GP4, 00000002338GP2, 00000002340GP8, 00000002366GP3, 00000002509M38, 00000002530GP4, 00000002557GP7, 00000002562GP7, 00000002569GP2, 00000002570GP0, 00000002609GQ6, 00000002615M33, 00000002624M35, 00000002635GP1, 00000002636GP9, 00000002637GP7, 00000002639GP3, 00000002669GP0, 00000002839GP9, 00000002840GP7, 00000002894GP4, 00000002922M33, 00000002997GP5, 00000003189GP8, 00000003190GP6, 00000003191GP4, 00000003240GP9, 00000003241GP7, 00000003244GP1, 00000003337GP3, 00000003338GP1, 00000003339GP9, 00000003341GP5, 00000003343GP1, 00000003431GP4, 00000003442GP1, 00000003444GP7, 00000003458GP7, 00000003518GP8, 00000003519GP6, 00000003520GP4, 00000003583GP2, 00000003619GP4, 00000003621GP0, 00000003622GP8, 00000003671GQ5, 00000003718GP4, 00000003719GP2, 00000003720GP0, 00000003721GP8, 00000003724GP2, 00000003726GP7, 00000003727GP5, 00000003802GP6, 00000003804GP2, 00000003929GP7, 00000003967GP7, 00000003968GP5, 00000003970GP1, 00000003972GP7, 00000003973GP5, 00000003976GP8, 00000004029GP5, 00000004030GP3, 00000004033GP7, 00000004034GP5, 00000004035GP2, 00000004036GP0, 00000004037GP8, 00000004038GP6, 00000004108GQ7, 00000004182M32, 00000004223GP4, 00000004224GP2, 00000004226GP7, 00000004271GP3, 00000004272GP1, 00000004273GP9, 00000004274GP7, 00000004275GP4, 00000004278GQ8, 00000004279GQ6, 00000004300GP0, 00000004301GP8, 00000004302GP6, 00000004303GP4, 00000004336GP4, 00000004396GP8, 00000004398GP4, 00000004478GP4, 00000004480GP0, 00000004481GP8, 00000004485GP9, 00000004486GP7, 00000004539M33, 00000004540M31, 00000004631GP8, 00000004662GP3, 00000004663GP1, 00000004664GP9, 00000004667GP2, 00000004668GP0, 00000004670GP6, 00000004671GP4, 00000004758GP9, 00000004761GP3, 00000004762GP1, 00000004763GP9, 00000004764GP7, 00000004765GP4, 00000004792GP8, 00000004794GP4, 00000004795GP1, 00000004796GP9, 00000004801GP7, 00000004814M30, 00000004825GQ6, 00000004933GP8, 00000004934GP6, 00000004979GP1, 00000004980GP9, 00000004982GP5, 00000004983GP3, 00000004984GP1, 00000004985GP8, 00000004986GP6, 00000004987GP4, 00000005022M39, 00000005114GP4, 00000005116GP9, 00000005117GP7, 00000005310GP8, 00000005312GP4, 00000005314GP0, 00000005314M30, 00000005315GP7, 00000005316GP5, 00000005317GP3, 00000005318GP1, 00000005389YY2, 00000005405GQ6, 00000005452GP8, 00000005472GP6, 00000005475GP9, 00000005476GP7, 00000005477GP5, 00000005537GP6, 00000005538GP4, 00000005542GP6, 00000005545GP9, 00000005546GP7, 00000005570M37, 00000005776GP0, 00000005782GP8, 00000005783GP6, 00000005784GP4, 00000005823M30, 00000006017GP8, 00000006018GP6, 00000006021GP0, 00000006022GP8, 00000006023GP6, 00000006024GP4, 00000006036GP8, 00000006052GP5, 00000006053GP3, 00000006054GP1, 00000006056GP6, 00000006145GP7, 00000006146GP5, 00000006167GP1, 00000006171M33, 00000006181M32, 00000006205M39, 00000006220GP8, 00000006221GP6, 00000006222GP4, 00000006225GP7, 00000006241GQ4, 00000006397GP4, 00000006424GP6, 00000006425GP3, 00000006426GP1, 00000006427GP9, 00000006428GP7, 00000006429GP5, 00000006430GP3, 00000006433GP7, 00000006434GP5, 00000006435GP2, 00000006436GP0, 00000006439GP4, 00000006490GQ7, 00000006808GP0, 00000006809GP8, 00000006811GP4, 00000006812GP2, 00000006813GP0, 00000006815GP5, 00000006915GP3, 00000006924GP5, 00000006928GP6, 00000006970GP8, 00000006971GP6, 00000006974GP0, 00000006975GP7, 00000006976GP5, 00000007022GP7, 00000007023GP5, 00000007024GP3, 00000007025GP0, 00000007026GP8, 00000007027GP6, 00000007028GP4, 00000007029GP2, 00000007030GP0, 00000007031GP8, 00000007101GP9, 00000007102GP7, 00000007103GP5, 00000007104GP3, 00000007185GP2, 00000007198GP5, 00000007202GP5, 00000007203GP3, 00000007204GP1, 00000007205GP8, 00000007206GP6, 00000007207GP4, 00000007210GP8, 00000007238GP9, 00000007254GP6, 00000007255GP3, 00000007256GP1, 00000007316GP3, 00000007325GP4, 00000007402GP1, 00000007403GP9, 00000007404GP7, 00000007405GP4, 00000007406GP2, 00000007407GP0, 00000007414GP6, 00000007417GP9, 00000007420GP3, 00000007421GP1, 00000007424GP5, 00000007426GP0, 00000007429GP4, 00000007430GP2, 00000007484M39, 00000007559M38, 00000007651M33, 00000007655GP4, 00000007656GP2, 00000007659GP6, 00000007660GP4, 00000007662GP0, 00000007664GP6, 00000007784GP2, 00000007827GP9, 00000007828GP7, 00000007954GP1, 00000007955GP8, 00000007960GP8, 00000007961GP6, 00000007962GP4, 00000007964GP0, 00000007965GP7, 00000007966GP5, 00000007995GP4, 00000008002GP8, 00000008050GP7, 00000008051GP5, 00000008052GP3, 00000008053GP1, 00000008054GP9, 00000008056GP4, 00000008057GP2, 00000008059GP8, 00000008201GP6, 00000008202GP4, 00000008203GP2, 00000008205GP7, 00000008208GP1, 00000008209GP9, 00000008211GP5, 00000008212GP3, 00000008213GP1, 00000008214GP9, 00000008215GP6, 00000008216GP4, 00000008217GP2, 00000008218GP0, 00000008310GP5, 00000008311GP3, 00000008312GP1, 00000008466GP5, 00000008513GP4, 00000008516GP7, 00000008517GP5, 00000008518GP3, 00000008519GP1, 00000008704GP9, 00000008706GP4, 00000008828GP6, 00000008829GP4, 00000008831GP0, 00000008833GP6, 00000008834GP4, 00000008835GP1, 00000008836GP9, 00000008837GP7, 00000008838GP5, 00000008839GP3, 00000008840GP1, 00000008841GP9, 00000008894GP8, 00000008906GP0, 00000008909GP4, 00000008911GP0, 00000008913GP6, 00000008914GP4, 00000008915GP1, 00000008916GP9, 00000008917GP7, 00000008917YY7, 00000008918GP5, 00000008920GP1, 00000008921GP9, 00000008922GP7, 00000008923GP5, 00000008924GP3, 00000009124GP9, 00000009126GP4, 00000009162GP9, 00000009169GP4, 00000009170GP2, 00000009263GP5, 00000009264GP3, 00000009265GP0, 00000009266GP8, 00000009268GP4, 00000009269GP2, 00000009272GP6, 00000009282GP5, 00000009476GQ3, 00000009482GQ1, 00000009485GQ4, 00000009569GP5, 00000009708M39, 00000009761GP8, 00000009762GP6, 00000009763GP4, 00000009764GP2, 00000009765GP9, 00000009766GP7, 00000009767GP5, 00000009771GP7, 00000009772GP5, 00000009773GP3, 00000009774GP1, 00000009777GP4, 00000009915GP0, 00000009917GP6, 00000009918GP4, 00000009919GP2, 00000009920GP0, 00000009921GP8, 00000009923GP4, 00000009925GP9, 00000009984GP6, 00000009985GP3, 00000009986GP1, 00000009987GP9, 00000009988GP7, 00000009991GP1, 0000000AI07112, 0000000AI08103, 0000000AT-0061, 00000010115MO5, 00000010202GP0, 00000010203GP8, 00000010205GP3, 00000010206GP1, 00000010208GP7, 00000010209GP5, 00000010257GP4, 00000010258GP2, 00000010259GP0, 00000010260GP8, 00000010261GP6, 00000010262GP4, 00000010263GP2, 00000010266GP5, 00000010287GP1, 00000010289GP7, 00000010291GP3, 00000010292GP1, 00000010293GP9, 00000010294GP7, 00000010296GP2, 00000010297GP0, 00000010301GP0, 00000010302GP8, 00000010303GP6, 00000010304GP4, 00000010325GP9, 00000010348M31, 00000010533M38, 00000010592GP4, 00000010759GP9, 00000010760GP7, 00000010761GP5, 00000010762GP3, 00000010764GP9, 00000010766GP4, 00000010767GP2, 00000010768GP0, 00000010769GP8, 00000010770GP6, 00000010800M31, 00000010811GP8, 00000010812GP6, 00000010812M36, 00000010813GP4, 00000010814GP2, 00000010815GP9, 00000010816GP7, 00000010817GP5, 00000010936GP3, 00000010940GP5, 00000010941GP3, 00000010942GP1, 00000010943GP9, 00000010944GP7, 00000010945GP4, 00000011089GP0, 00000011090GP8, 00000011091GP6, 00000011093GP2, 00000011094GP0, 00000011095GP7, 00000011096GP5, 00000011097GP3, 00000011100GP5, 00000011193GP0, 00000011194GP8, 00000011195GP5, 00000011197GP1, 00000011198GP9, 00000011201GP1, 00000011203GP7, 00000011205GP2, 00000011206GP0, 00000011207GP8, 00000011208GP6, 00000011209GP4, 00000011210GP2, 00000011211GP0, 00000011212GP8, 00000011214GP4, 00000011215GP1, 00000011216GP9, 00000011217GP7, 00000011219GP3, 00000011220GP1, 00000011387M38, 00000011481GP9, 00000011482GP7, 00000011483GP5, 00000011484GP3, 00000011486GP8, 00000011487GP6, 00000011488GP4, 00000011489GP2, 00000011490GP0, 00000011644GP2, 00000011646GP7, 00000011934GP7, 00000011935GP4, 00000011936GP2, 00000011937GP0, 00000011938GP8, 00000011939GP6, 00000011940GP4, 00000011942GP0, 00000011943GP8, 00000011946GP1, 00000011948GP7, 00000011950GP3, 00000011951GP1, 00000011952GP9, 00000011953GP7, 00000012156GP6, 00000012157GP4, 00000012158GP2, 00000012159GP0, 00000012160GP8, 00000012161GP6, 00000012162GP4, 00000012163GP2, 00000012164GP0, 00000012165GP7, 00000012367GP9, 00000012368GP7, 00000012369GP5, 00000012370GP3, 00000012371GP1, 00000012374GP5, 00000012375GP2, 00000012377GP8, 00000012378GP6, 00000012379GP4, 00000012380GP2, 00000012381GP0, 00000012382GP8, 00000012383GP6, 00000012386GP9, 00000012387GP7, 00000012388GP5, 00000012389GP3, 00000012390GP1, 00000012392GP7, 00000012393GP5, 00000012394GP3, 00000012396GP8, 00000012558GP3, 00000012559GP1, 00000012560GP9, 00000012562GP5, 00000012563GP3, 00000012566GP6, 00000012729GP0, 00000012731GP6, 00000012732GP4, 00000012733GP2, 00000012734GP0, 00000012735GP7, 00000012736GP5, 00000012737GP3, 00000012739GP9, 00000012741GP5, 00000012744GP9, 00000012746GP4, 00000012747GP2, 00000012748GP0, 00000012749GP8, 00000012750GP6, 00000012752GP2, 00000012753GP0, 00000012754GP8, 00000012755GP5, 00000012756GP3, 00000012757GP1, 00000012758GP9, 00000012759GP7, 00000012760GP5, 00000012761GP3, 00000012762GP1, 00000012764GP7, 00000012765GP4, 00000012766GP2, 00000012767GP0, 00000012768GP8, 00000012879GP3, 00000012880GP1, 00000012883GP5, 00000012884GP3, 00000012886GP8, 00000012888GP4, 00000013207GP6, 00000013208GP4, 00000013209GP2, 00000013210GP0, 00000013211GP8, 00000013212GP6, 00000013213GP4, 00000013214GP2, 00000013215GP9, 00000013217GP5, 00000013218GP3, 00000013220GP9, 00000013221GP7, 00000013222GP5, 00000013223GP3, 00000013224GP1, 00000013225GP8, 00000013226GP6, 00000013227GP4, 00000013229GP0, 00000013443GP7, 00000013444GP5, 00000013446GP0, 00000013447GP8, 00000013448GP6, 00000013449GP4, 00000013450GP2, 00000013567GP3, 00000013568GP1, 00000013569GP9, 00000013570GP7, 00000013571GP5, 00000013572GP3, 00000013923GP8, 00000013924GP6, 00000013925GP3, 00000013927GP9, 00000013929GP5, 00000013930GP3, 00000013931GP1, 00000013932GP9, 00000014086GP3, 00000014087GP1, 00000014090GP5…

Recall started

Nov. 8, 2013

Device type

System, X-Ray, Fluoroscopic, Image-Intensified

Root cause (FDA)

Employee error

What the company told customers

GE Healthcare Systems sent an " Urgent Medial Device Correction" letter dated November 7, 2013. The letter was addressed to Hospital Administrators / Risk Mangers, Managers of Radiology /Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (USA 800-437-1171, Japan 0120-055-919, For other countries, please contact your local GE Healthcare Service Representative).

Recall number

Z-0804-2014

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0804-2014. The agency record governs; check it and the company before acting.