Z-2402-2012Class II

A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table

Name: Z-2402-2012 A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table
Creator: Steris Corporation
Published: 2010-02-17
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2010-02-17 / Terminated / root cause: manufacturing process

FDA source

Steris Corporation began a recall of A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use... on 2010-02-17. FDA classified it as Class II and gives the reason as "Customers may be storing objects on the base and/or around the column of the surgical table. This prohibited practice and misuse known by the customers can damage the override switch assembly located at the top of 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-2402-2012
Classification: Class II
Status: Terminated
Initiated: 2010-02-17
Posted: 2012-09-17
Terminated: 2013-03-13
Recalling firm: STERIS Corporation
Product: A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable components and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: Customers may be storing objects on the base and/or around the column of the surgical table. This prohibited practice and misuse known by the customers can damage the override switch assembly located at the top of the column cover. Depending upon the nature and severity of the damage to the electronics of the table, it is possible that the table could move without prompting by an operator .
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Steris sent an Urgent Field Correction Notice letter dated February 17, 2010 to their customers. The letter identified the affected product, description of the problem and actions to be taken. Customers were instructed to examine their units for any structural damage. If found they are to discontinue use and arrange for a field representative to visit the facility to assess the damages and arrange for repair of the unit. For information or questions regarding STERIS visit to your facility contact STERIS Field Service Dispatch at 1-800-333-8828.
Quantity in commerce: 11,044 Units
Distribution: Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico and the following countries: American Samoa, Argentina, Australia, Bahrain, Bangladesh, Bermuda, Brazil, Canada, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Germany, Greece, Guam, Hong Kong, India, Indonesia, Israel, Italy, Japa, Jordan, Kazakhstan, Korea, Kuwait, Lebanon , Libya , Malaysia , Mexico, Morocco, New Zealand, Panama, Peru, Philippines , Poland, Portugal, Qatar, Russia, Saudi Arabia , Singapore, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Trinidad and Tobago, Turkey & United Kingdom.
Product codes and lots: B420702032 to 0402110097

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2402-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2402-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-17

Product code FQO

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