Recall Z-2402-2012— Steris Corporation

Class II FDA medical device recall by Steris Corporation, initiated 2010-02-17, terminated 2013-03-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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 ..

Recalling firm

Steris Corporation

Classification

Class II

Status

Terminated

Initiated

2010-02-17

Terminated

2013-03-13

Firm location

Mentor, OH, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.