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U.S. Department of Health and Human Services

Class 2 Device Recall Stille Sonesta Video Fluoroscopy Table 6210

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  Class 2 Device Recall Stille Sonesta Video Fluoroscopy Table 6210 see related information
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
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
Manufacturer Reason
for Recall		 Bolts may back out of their joints causing the back section of the table to tilt.
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
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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