Date Initiated by Firm | October 17, 2011 |
Date Posted | November 23, 2011 |
Recall Status1 |
Terminated 3 on March 19, 2013 |
Recall Number | Z-0279-2012 |
Recall Event ID |
60305 |
510(K)Number | K090136 |
Product Classification |
surgical tables - Product Code FQO
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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 OH 44060-1834
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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 | 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 |
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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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510(K) Database | 510(K)s with Product Code = FQO
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