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 fo
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling video monitor suspensions used in overhead installations on multiple fluoroscopic and radiographic X-ray systems, including the Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, and Prestige VH models. The defect involves four outer screws that secure the video monitor suspension to the carriage being missing since the systems were initially installed. Approximately 5,651 affected units have been distributed worldwide, including throughout the United States, U.S. territories, and numerous countries internationally. Although GE is aware of no incidents involving the monitor suspension falling, the missing screws create a potential safety hazard.
The recall notice does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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: 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, Egyp Quantity: 5651 Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.