STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6.
FDA Recall Z-0279-2012 · Posted 2011-11-23
Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeFQO
Date Initiated2011-10-17
Date Terminated2013-03-19
Product Quantity167 tables were distributed - 5085=108 and 5085SRT=59
Reason for Recall
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.
Firm Action
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).
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.