Recall Z-1248-2015 ยท KPR System, X-Ray, Stationary
GE Healthcare
GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
| Date | Mar 6, 2015 (initiated Jan 30, 2015) |
| Status | Terminated |
| Reason | Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result in an injury to a patient or operator. |
| Root cause | Device Design |
| Action | Consignees were sent on 1/30/2015 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#17108 dated January 30, 2015. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology, and Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact 800-437-1171. Outside the US contact your local GE Healthcare Service Representative. |
| Quantity | 192 (131 US, 61 OUS). |
| Distribution | Worldwide Distribution-US (nationwide) including the states of AK, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI,and WV, and the countries of ARGENTINA, CANADA, CHILE, CZECH REPUBLIC, FRANCE, GERMANY, GREECE, HONG KON |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993090 | SILHOUETTE FC Ge Medical Systems, Inc., Oct 1, 1999 |