Z-0279-2012

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

Name: Z-0279-2012 STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6
Creator: Steris Corporation
Published: 2011-10-17
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2011-10-17 / Terminated / root cause: manufacturing process

FDA source

Steris Corporation began a recall of STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6 on 2011-10-17. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0279-2012
Status: Terminated
Initiated: 2011-10-17
Posted: 2011-11-23
Terminated: 2013-03-19
Recalling firm: STERIS Corporation
Product: STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6.
Product code: FQO Table, Operating-Room, Ac-Powered
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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).
Quantity in commerce: 167 tables were distributed - 5085=108 and 5085SRT=59
Distribution: Nationwide distribution.
Product codes and lots: 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).

Product code FQO

K090136Class ISteris Cmax Xlt Surgical TableSTERIS Corporation / cleared 2009-03-20

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)