Recall Z-0504-2007 ยท IXR Table, Radiographic, Tilting
Stille-Sonesta, Inc
Stille Sonesta Video Fluoroscopy Table 6210; manufactured by Stille AB, Solna, Sweden.
| Date | Feb 15, 2007 (initiated Nov 9, 2006) |
| Status | Terminated |
| Reason | Bolts may back out of their joints causing the back section of the table to tilt. |
| Root cause | Other |
| Action | Notifications letters sent to consignees on 11/20/06. Users are instructed to check the bolts located under the table. The Notice includes instructions with pictures for checking the bolts and tightening them if necessary. Stille AB has developed a kit for replacing the bolt that is involved and will send a service engineer out to the site to do the replacement. |
| Quantity | 66 units. |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.