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Class 2 Device Recall Stille Sonesta Video Fluoroscopy Table 6210 |
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Date Initiated by Firm |
November 09, 2006 |
Date Posted |
February 15, 2007 |
Recall Status1 |
Terminated 3 on June 20, 2007 |
Recall Number |
Z-0504-2007 |
Recall Event ID |
36855 |
Product Classification |
Fluoroscopy Table - Product Code IXR
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Product |
Stille Sonesta Video Fluoroscopy Table 6210; manufactured by Stille AB, Solna, Sweden. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Stille-Sonesta, Inc 2220 Canton St Apt 209 Dallas TX 75201-5932
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Manufacturer Reason for Recall |
Bolts may back out of their joints causing the back section of the table to tilt.
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FDA Determined Cause 2 |
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 in Commerce |
66 units. |
Distribution |
Nationwide. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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