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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 Recall
ASC2000 Ambulatory Surgical Table
see related information
Date Posted July 07, 2009
Recall Status1 Open
Recall Number Z-1597-2009
Recall Event ID 51953
Product Classification Table, Operating-Room, Electrical - 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, Ohio 44060
Consumer Instructions Contact the recalling firm for information
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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