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
This recall has been terminated (originally issued October 20, 2008).
- Company
- Stille Ab Gardsvagen
- Recall Initiated
- August 27, 2008
- Posted
- October 20, 2008
- Terminated
- December 10, 2010
- Recall Number
- Z-0119-2009
- Quantity
- 114 units
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Nationwide and Canada
Lot / Code Info
Model 6210, all serial numbers
Root Cause
Component design/selection
Action Taken
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 enclosed acknowledgement card to Stille by fax or e-mail as soon as possible and no later than 9/26/08. The accounts were advised to not further use the table in conjunction with a C-arm or any other heavy object until a service technician can permanently remove the battery from the control box according to the enclosed Service Manual Amendment No. 1. Stille will make a permanent correction to the table once it has been validated and approved. Contact Stille Surgical Inc. at 1-800-655-1614 for assistance.