—#104997

Product

STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6.

FDA product code: FQO — Table, Operating-Room, Ac-Powered
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K090136
Affected lot / code info: Tables identified with the following Codes are subject to correction: 0401510077 to 0421411110. (Note: not all tables manufactured in this range are affected by this voluntary field correction).

Why it was recalled

Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by their supplier with incorrect snap rings and an anomaly was present in the tilt cylinder. This error may affect the user's ability to move the table top out of the full right tilt position.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On October 17, 2011, Steris sent 'Urgent Voluntary Field Correction Notices' to their customers via Fedex with tracking numbers for delivery confirmation. The letter identifies the affected product and notifies the user/customers of the problem with the surgical tables. The notification letter goes on to inform the customers that a STERIS Service Representative will be contacting them to arrange for the field correction of the affected unit(s). This involves the replacement of the hydraulic column cylinder of each surgical table(s).

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: Nationwide distribution.

Timeline

Recall initiated: 2011-10-17
Posted by FDA: 2011-11-23
Terminated: 2013-03-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104997. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.