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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical Tables

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 Class 2 Recall
Surgical Tables
see related information
Date Posted September 20, 2012
Recall Status1 Terminated on September 04, 2013
Recall Number Z-2426-2012
Recall Event ID 63142
Premarket Notification
510(K) Number
K090136 
Product Classification Table, Operating-Room, Electrical - Product Code GDC
Product STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. It accommodates all general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients. The 5085SRT table is a variation of the 5085 table that enables patient transport on hard level surfaces within the surgical suite (from pre-operative areas to the operating room and again from the operating room to post operative recovery).
Code Information Serial numbers from 0403809001 to 0408612102
Recalling Firm/
Manufacturer
Steris Corporation
5960 Heisley Rd
Mentor, Ohio 44060-1834
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Eric Wittine
440-392-7148
Manufacturer Reason
for Recall
STERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless steel shroud sections covering the table hydraulic column to become misaligned; if the damage is severe, the up/down movement of the table may be impeded. In addition, the table hand control may indicate that the table floor locks are unlock
FDA Determined
Cause 2
DESIGN: Device Design
Action Steris sent an Urgent Voluntary Field Correction Notice dated April 6, 2012 to all affected customer. The letter identified the affected product, description of the problem and actions to be taken. Customers were informed that a STERIS Service Representative will contact affected facility to arrange for the replacement of the stainless steel shroud covering the hydraulic column and relocation of the floor lock pressure switches on their 5085 and/or 5085SRT table(s). For further information or if you have questions regarding the visit to your facility, contact STERIS Field Service Dispatch at 1-800-333-8828. If you have questions regarding this matter, call the Director of Marketing Tables and Case Goods at 440-392-7148 or STERIS Customer Service at 1-800-548-4873.
Quantity in Commerce 379 tables
Distribution Worldwide Distribution - US Nationwide including the states of: AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, IA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NV, NYH, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WI & WV and countries of: Australia, Canada, China, India, Korea, Mexico, Panama 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.
510(K) Database 510(K)s with Product Code = GDC and Original Applicant = STERIS Corporation
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