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U.S. Department of Health and Human Services

Class 2 Device Recall STERIS 5085 and 5085SRT surgical tables

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 Class 2 Recall
STERIS 5085 and 5085SRT surgical tables
see related information
Date Posted November 23, 2011
Recall Status1 Terminated on March 19, 2013
Recall Number Z-0279-2012
Recall Event ID 60305
Premarket Notification
510(K) Number
K090136 
Product Classification Table, Operating-Room, Ac-Powered - Product Code FQO
Product STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6.
Code Information Tables identified with the following Codes are subject to correction: 0401510077 to 0421411110. (Note: not all tables manufactured in this range are affected by this voluntary field correction).
Recalling Firm/
Manufacturer
Steris Corporation
5960 Heisley Rd
Mentor, Ohio 44060-1834
For Additional Information Contact Eric Wittine
440-392-7601
Manufacturer Reason
for Recall
Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by their supplier with incorrect snap rings and an anomaly was present in the tilt cylinder. This error may affect the user's ability to move the table top out of the full right tilt position.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action On October 17, 2011, Steris sent 'Urgent Voluntary Field Correction Notices' to their customers via Fedex with tracking numbers for delivery confirmation. The letter identifies the affected product and notifies the user/customers of the problem with the surgical tables. The notification letter goes on to inform the customers that a STERIS Service Representative will be contacting them to arrange for the field correction of the affected unit(s). This involves the replacement of the hydraulic column cylinder of each surgical table(s).
Quantity in Commerce 167 tables were distributed - 5085=108 and 5085SRT=59
Distribution Nationwide distribution.
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.
510(K) Database 510(K)s with Product Code = FQO and Original Applicant = STERIS CORPORATION
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