Stille Sonesta Video Fluoroscopy Table 6210; manufactured by Stille AB, Solna, Sweden.
This recall has been terminated (originally issued February 15, 2007).
- Company
- Stille-Sonesta, Inc
- Recall Initiated
- November 9, 2006
- Posted
- February 15, 2007
- Terminated
- June 20, 2007
- Recall Number
- Z-0504-2007
- Quantity
- 66 units.
- Firm Location
- Dallas, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Bolts may back out of their joints causing the back section of the table to tilt.
Distribution
Nationwide.
Lot / Code Info
Serial Numbers: 12-70000 - 12-70017, 00010, 00012, 00013 - 00022, 00024 - 00027, 00030 - 00034, 00036 - 00040, 00043 - 00044, 00045 - 00049, 00053 - 00054, 00057 - 00065, 00067 - 00069, 00071. Outside U.S. Serial Numbers: 12-70018 - 12-70019, 23-70000 - 23-70009, 23-70008, 23-700010, 00011, 00023, 00028 - 00029, 00050 - 00052, 00055 - 00056, 00066, 00072, 00073, 00074.
Root Cause
Other
Action Taken
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.