Recall Z-0003-2009 ยท KPR System, X-Ray, Stationary
GE Medical Systems, LLC
Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.
| Date | Sep 22, 2009 (initiated Feb 14, 2008) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of an error in the generator software on the Revolution XR/d configured with HP 8200 PC consoles that reports a mAs reading that is higher than is actually exposed to patients. |
| Root cause | Software design |
| Action | Consignees were sent a GE Healthcare "Product Safety Notification" letter dated March 7, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology, and Radiologists. The letter listed the Safety Issue, Affected Product, Safety Instructions, and Contact Information. |
| Quantity | 83 (63 USA, 20 OUS) |
| Distribution | Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, ID, IL, IN, LA, MA, MI, MO, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA, and WI and countries of Canada, China, Japan, Korea, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051967 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS GE Healthcare, Aug 9, 2005 |