Recall Z-1822-2008 ยท KPR System, X-Ray, Stationary
GE Healthcare
GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis.
| Date | Sep 25, 2008 (initiated Mar 7, 2008) |
| Status | Terminated |
| Reason | Loss of image data: Software anomaly in the Processing Software on the Definium 8000 system may impact patient safety when using the VolumeRAD advanced application (option). The slice visualization of VolumeRAD exams acquired on the Wallstand receptor will be offset by 17mm. This prevents the visualization of anatomy WITHIN a distance of 17mm from the wallstand patient barrier (receptor cover). |
| Root cause | Software design |
| Action | GE sent a Product Safety Notification, dated March 7, 2008, to all customers. The letter described the safety issue, products affected, and stated that a GE Healthcare Field Engineer will schedule a visit to each facility to install a software modification. |
| Quantity | 127 |
| Distribution | Worldwide distribution: USA, Australia, Belgium, Canada, China, Finland, France, Germany, Great Britain, Italy, Netherlands, Spain, and Sweden. |
| 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 |