ASC2000 Ambulatory Surgical Table. Model #MTS110003. The device is used to provide complete and flexible positioning for

FDA device recall Z-1597-2009 · posted 2009-07-07 · Terminated

Recall details

Recalling firm

Steris Corp

Reason for recall

Upon investigation, the firm determined that repetitive rubbing of the hydraulic hoses against the interior of the stainless steel shroud may result in the rupture of the hydraulic hoses causing loss of control of the table surface.

Action taken

A Field Correction Notice dated April 17, 2009 was issued to customers. The letter described the potential problem of the unit. The letter also notified customers of the corrective actions to be taken by the firm. A Steris technician will visit affected accounts to inspect the hydraulic hoses and replace any that show abrasion and will make other preventive corrections. For further information or if you have questions regarding the servicing of your unit, please contact the STERIS Field Service Dispatch at 1-800-288-2805.

Root cause

Device Design

Status

Terminated

Product code

GDC

Quantity affected

412 units

Distribution

Worldwide Distribution -- US (states of AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MD, MI, MN, MO, NC, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, VA and WV), AUSTRALIA, BANGLADESH, BELGIUM,

Date initiated

2009-04-17

Date posted

2009-07-07

Date terminated

2012-03-01

Location

Mentor, OH