Recall Z-1036-04 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Advance Medical Designs Inc
Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, GA 80066 USA.
| Date | Jul 20, 2004 (initiated Jun 18, 2004) |
| Status | Terminated |
| Reason | The product may come apart when excessive force is applied to the coupler. |
| Root cause | Other |
| Action | Consignees were notified on 6/17/2004 first by telephone on 6/17/2004 with f/u letter sent 6/18/04. |
| Quantity | 2340 units, *amended to include additional 250 units |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K850959 | EQUIPMENT SNAP KOVERS Advance Medical Designs, Inc., Apr 9, 1985 |