Recall Z-0804-2014 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE Healthcare, LLC
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 ar
| Date | Jan 21, 2014 (initiated Nov 8, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| Action | 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). |
| Quantity | 5651 |
| 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, Colo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011624 | EXPEDIO 500D R&F X-RAY SYSTEM GE Medical Systems, Jun 8, 2001 |
| K081091 | PRECISION 500D R&F X-RAY SYSTEM GE Healthcare, Jun 11, 2008 |
| K801320 | SFX-90 TABLE/SPOTFILMER W/FLUORICON L200 General Electric Co., Jul 21, 1980 |
| K862120 | SCX SYSTEM General Electric Co., Jun 16, 1986 |
| K936180 | TC+ SYSTEM (TILTING C-ARM SYSTEM) GE Medical Systems, Mar 16, 1994 |
| K943805 | PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD General Electric Co., Sep 23, 1994 |