Recall Z-0002-2009 ยท KPR System, X-Ray, Stationary
GE Medical Systems, LLC
Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
| Date | Sep 24, 2009 (initiated Feb 14, 2008) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure on Revolution XR/d systems equipped with HP 8200 PC user consoles that may impact patient safety. It was reported that images acquired with off-center collimation for extremities with the position selected as Digits to front or Digits to back are displayed as blank. Investigation into th |
| 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, Corrective Action and Contact Information. |
| Quantity | 129 |
| Distribution | Nationwide Distribution -- AL, AZ, CA, CO, FL, GA, HI, IL , IN, KY, LA, MD, MA, MI,MN,MS, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK OR, PA, SC, TN, TX, VA, WA, and WV. |
| 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 |