Recall Z-1065-2012 ยท KPR System, X-Ray, Stationary
GE Healthcare, LLC
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.
| Date | Feb 21, 2012 (initiated Oct 26, 2011) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential issue associated with the hand grip that is clamped to the table top of your Revolution XRD X-ray systems that may impact patient safety. The hand grip accessory that is clamped to the table top may not be properly adjusted and can dislodge during use. Should this happen during patient loading or unloading, patient injury could occur. |
| Root cause | Device Design |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated October 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to remove the hand grip accessory from use until the product is corrected and to take extra precautions when loading or unloading patients from the table while the hand grips are not in use. A GE Healthcare service representative would contact the consignee to arrange for the correction. For questions regarding this recall call 262-513-4122. |
| Quantity | 772 |
| Distribution | Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WY, WI and the countries of VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, |
| 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 |