Z-0504-2007

Stille Sonesta Video Fluoroscopy Table 6210; manufactured by Stille AB, Solna, Sweden

Name: Z-0504-2007 Stille Sonesta Video Fluoroscopy Table 6210; manufactured by Stille AB, Solna, Sweden
Creator: Stille-Sonesta, Inc
Published: 2006-11-09
License: https://open.fda.gov/license/

Stille Surgical Inc. / initiated 2006-11-09 / Terminated

FDA source

Stille-Sonesta, Inc began a recall of Stille Sonesta Video Fluoroscopy Table 6210; manufactured by Stille AB, Solna, Sweden on 2006-11-09. The reason FDA records is "Bolts may back out of their joints causing the back section of the table to tilt". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0504-2007
Status: Terminated
Initiated: 2006-11-09
Posted: 2007-02-15
Terminated: 2007-06-20
Recalling firm: Stille Surgical Inc.
Product: Stille Sonesta Video Fluoroscopy Table 6210; manufactured by Stille AB, Solna, Sweden.
Product code: IXR Table, Radiographic, Tilting
Reason for recall: Bolts may back out of their joints causing the back section of the table to tilt.
FDA root cause: 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.
Product codes and lots: 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.

Product code IXR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)