A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product p

FDA device recall Z-2402-2012 · posted 2012-09-17 · Terminated

Recall details

Recalling firm

Steris Corporation

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 .

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

FQO

Quantity affected

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, C

Date initiated

2010-02-17

Date posted

2012-09-17

Date terminated

2013-03-13

Location

Mentor, OH