• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Stille Sonesta Video Fluoroscopy Table 6210

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Stille Sonesta Video Fluoroscopy Table 6210
see related information
Date Posted February 15, 2007
Recall Status1 Terminated on June 20, 2007
Recall Number Z-0504-2007
Recall Event ID 36855
Product Classification Table, Radiographic, Tilting - 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, Texas 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
PRODUCTION CONTROLS: Process Control
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-