Recall Z-0787-05 ยท IYB Tube Mount, X-Ray, Diagnostic
Fischer Imaging Corporation
VersaRad Generator
| Date | May 3, 2005 (initiated Sep 30, 2004) |
| Status | Terminated |
| Reason | Some VersaRad Systems have a faulty weld that may result in oil leakage. |
| Root cause | Other |
| Action | Customers were sent notification letters. |
| Quantity | 38 units |
| Distribution | Domestic distribution: ... International distribution: Germany, Greece, Italy, Kuwait, Spain, Sweden, Switzerland. No VA or military facilities. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880530 | CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX Fischer Imaging Corp., Mar 3, 1988 |