Recall Z-0842-2008 ยท KPR System, X-Ray, Stationary
GE Healthcare
GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the Silhouette FC, GE Healthcare, Waukesha, WI 53188.
| Date | Jun 10, 2008 (initiated Nov 1, 2007) |
| Status | Terminated |
| Reason | The warning label that is required by 21 CFR 1020.30(j) was not on the control console of the Proteus XR/a Radiographic X-ray System, Model 2259976. |
| Root cause | Process control |
| Action | GE issued a Field Modification Instruction to their field service representatives, released in December 2007, with instructions to replace the labels on the console with the appropriate labeling. Consignees will be visited by GE field service representatives beginning December 2007. All consignees will have the required labels affixed to their units by July 31, 2008. |
| Quantity | 400 Units |
| Distribution | Worldwide Distribution, including USA, Canada, Mexico, France, Hong Kong, Italy, Korea, China, Poland, UK, New Zealand, Saudi Arabia, Taiwan, Turkey, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993090 | SILHOUETTE FC Ge Medical Systems, Inc., Oct 1, 1999 |