Recall Z-0010-2015 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE Healthcare, LLC
GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations.
| Date | Oct 2, 2014 (initiated Sep 5, 2014) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems. |
| Root cause | Employee error |
| Action | Consignees were sent on 9/5/2014 a GE Healthcare "Urgent Medical Device Letter" GE Ref:10893, dated September 5, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Cardiology & Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions in USA call 800-437-1171, for other countries contact your local GE Healthcare Service Representative. |
| Quantity | 204 (199 US, 5 OUS). |
| Distribution | Worldwide Distribution - US Nationwide - AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI and in the countries CANADA, GERMANY, UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081091 | PRECISION 500D R&F X-RAY SYSTEM GE Healthcare, Jun 11, 2008 |