Recall Z-0335-06 ยท IYB Tube Mount, X-Ray, Diagnostic
Siemens Medical Solutions USA, Inc
3D TOP Ceiling Stand. X-Ray System model number 8773673
| Date | Dec 31, 2005 (initiated Nov 30, 2005) |
| Status | Terminated |
| Reason | screws on the rollers may become loose |
| Root cause | Other |
| Action | The recalling firm has issued a field correction per Update Instructions AX004/06/S. This update instructs a Siemens Customer Service Engineer to visit affected consignees and checkthe screws on the rollers. It also provides roller bearing sleeves as a secondary safety mechanism to prevent the rollers from detaching. |
| Quantity | 460 units |
| Distribution | The products were shipped to hospitals and medical facilities nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K802200 | VERTIX 3D-U Siemens Corp., Oct 23, 1980 |