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Terminated

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

FDA Recall Z-0504-2007 · Posted 2007-02-15

Recalling FirmStille-Sonesta, Inc
Recall StatusTerminated
Product CodeIXR
Date Initiated2006-11-09
Date Terminated2007-06-20
Product Quantity66 units.

Reason for Recall

Bolts may back out of their joints causing the back section of the table to tilt.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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