Z-1597-2009

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

Name: Z-1597-2009 ASC2000 Ambulatory Surgical Table. Model #MTS110003. The device is used to provide complete and flexible...
Creator: Steris Corp
Published: 2009-04-17
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2009-04-17 / Terminated / root cause: design

FDA source

Steris Corp began a recall of ASC2000 Ambulatory Surgical Table. Model #MTS110003. The device is used to provide complete and flexible positioning for surgical procedures on 2009-04-17. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1597-2009
Status: Terminated
Initiated: 2009-04-17
Posted: 2009-07-07
Terminated: 2012-03-01
Recalling firm: STERIS Corporation
Product: ASC2000 Ambulatory Surgical Table. Model #MTS110003. The device is used to provide complete and flexible positioning for surgical procedures.
Product code: GDC Table, Operating-Room, Electrical
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 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, BRAZIL, CANADA, CHINA, COLOMBIA, ECUADOR, GERMANY, HONG KONG, INDIA, INDONESIA, ITALY, KOREA, MEXICO, PHILIPPINES, PORTUGAL, SINGAPORE, SPAIN, SRI LANKA and THAILAND.
Product codes and lots: All serial numbers.

Product code GDC

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)