Recall Z-1327-04 ยท FQO Table, Operating-Room, Ac-Powered
Allen Medical Systems
Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table Catalog No: MDTNA2
| Date | Aug 7, 2004 (initiated Jul 12, 2004) |
| Status | Terminated |
| Reason | Neuro adapter may fail to engage and adequately clamp to the surgical table, resulting in movement |
| Root cause | Other |
| Action | Allen Medical notified the two distributors by telephone on 7/12/04 and 7/16/04. A customer notifcation letter issued requesting return of the device for correction. |
| Quantity | 29 units |
| Distribution | SC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.