FDAFDA · Alimentos y medicamentos·N.º oficial 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.
Publicado el 29 de enero de 2014 · Inicio del retiro: 8 de noviembre de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- 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.
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States