STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight c

FDA device recall Z-2426-2012 · posted 2012-09-20 · Terminated

Recall details

Recalling firm

Steris Corporation

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

GDC

Quantity affected

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,

Date initiated

2012-04-06

Date posted

2012-09-20

Date terminated

2013-09-04

Location

Mentor, OH

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