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U.S. Department of Health and Human Services

Class 2 Device Recall ASC2000 Ambulatory Surgical Table

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  Class 2 Device Recall ASC2000 Ambulatory Surgical Table see related information
Date Initiated by Firm April 17, 2009
Date Posted July 07, 2009
Recall Status1 Terminated 3 on March 01, 2012
Recall Number Z-1597-2009
Recall Event ID 51953
Product Classification Ambulatory Surgical Table - Product Code GDC
Product ASC2000 Ambulatory Surgical Table. Model #MTS110003.

The device is used to provide complete and flexible positioning for surgical procedures.
Code Information All serial numbers.
Recalling Firm/
Manufacturer		 Steris Corp
5960 Heisley Rd
Mentor OH 44060
For Additional Information Contact Barbara Rich
440-392-7318
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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