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FDAFDA · Food and drugs·Recall number Z-0804-2014

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.

Published January 29, 2014 · Recall initiated: November 8, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
GE Healthcare, LLC
Distributor
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.
Lot
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, 0
Risk classification
Class II
Area (FDA)
device
Country
United States

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