Recall Z-0584-2012 ยท KPR System, X-Ray, Stationary
GE Healthcare, LLC
GE Healthcare Definium 8000, Digital Radiographic Systems. Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
| Date | Jan 11, 2012 (initiated Nov 22, 2011) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential issue associated with the patient barrier rotating arm that is a part of the Definium 8000 and Discovery XR650 image pasting systems that may impact patient and user safety. The patient barrier rotating arms that are used to position and stabilize the patient during image pasting procedures may fail to retain residual friction at the arm pivot. Thi |
| Root cause | Device Design |
| Action | The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 17, 2011 to its customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The customers were instructed to ensure that all potential users in their facility are made aware of this safety notification and the recommended actions; discontinue use of the patient barrier and remove from service (away from patients) if either one the rotating arm locking levers is damaged (does not hold the rotating arm in place when engaged); |
| Quantity | 631 |
| Distribution | Worldwide distribution: USA (nationwide) including states of: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID,IL, IN, IA, KS, KY, LA,ME, MD, MA, MI, MN, MS, MO, MT, NH, NJ, NM, NY,NC, OH, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY; and countries of: VENEZUELA, UNITED KINGDOM, UNITED |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050704 | MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING General Electric Co., Apr 8, 2005 |