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U.S. Department of Health and Human Services

Class 2 Device Recall Amsco 3085SP Surgical Table

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  Class 2 Device Recall Amsco 3085SP Surgical Table see related information
Date Initiated by Firm February 17, 2010
Date Posted September 17, 2012
Recall Status1 Terminated 3 on March 13, 2013
Recall Number Z-2402-2012
Recall Event ID 54705
Product Classification Table, operating-room, ac-powered - Product Code FQO
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.
Code Information B420702032 to 0402110097
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060
For Additional Information Contact Lindsey McGowan
440-392-7519
Manufacturer Reason
for Recall		 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 .
FDA Determined
Cause 2		 Employee error
Action Steris sent an Urgent Field Correction Notice letter dated February 17, 2010 to their customers. The letter identified the affected product, description of the problem and actions to be taken. Customers were instructed to examine their units for any structural damage. If found they are to discontinue use and arrange for a field representative to visit the facility to assess the damages and arrange for repair of the unit. For information or questions regarding STERIS visit to your facility contact STERIS Field Service Dispatch at 1-800-333-8828.
Quantity in Commerce 11,044 Units
Distribution Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico and the following countries: American Samoa, Argentina, Australia, Bahrain, Bangladesh, Bermuda, Brazil, Canada, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Germany, Greece, Guam, Hong Kong, India, Indonesia, Israel, Italy, Japa, Jordan, Kazakhstan, Korea, Kuwait, Lebanon , Libya , Malaysia , Mexico, Morocco, New Zealand, Panama, Peru, Philippines , Poland, Portugal, Qatar, Russia, Saudi Arabia , Singapore, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Trinidad and Tobago, Turkey & United Kingdom.
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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