Recall Z-0119-2009 ยท IXR Table, Radiographic, Tilting
Stille AB
Sonesta 6210 Fluoroscopy Procedure Table; a motorized procedure table with adjustments (via a remote control) for height, tilt, back and seat cushion position; Stille Surgical AB, Sundbybergsvagen 1A, SE-17173 Solna, Sweden
| Date | Oct 20, 2008 (initiated Aug 27, 2008) |
| Status | Terminated |
| Reason | The table contains a battery backup, not mentioned in the User Manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. However, if a short circuit occurs, it can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply, as the battery automatically w |
| Root cause | Component design/selection |
| Action | Stille sent Field Safety Notices dated 8/27/08 to the direct accounts, informing them that the table contains a battery backup, not mentioned in the User Manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. However, if a short circuit occurs, it can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply, as the battery automatically will supply continuous power to the control box. The accounts were requested to complete and return the enclos |
| Quantity | 114 units |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.