Class 2 Device Recall Surgical Tables

• Date Initiated by Firm: April 06, 2012
• Date Posted: September 20, 2012
• Recall Status: Terminated on September 04, 2013
• Recall Number: Z-2426-2012
• Recall Event ID: 63142
• 510(K)Number: K090136
• Product Classification: Table, operating-room, ac-powered - 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 OH 44060-1834
• 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: 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 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.

• 510(K) Database: 510(K)s with Product Code = GDC and Original Applicant = STERIS Corporation