Recall Z-0196-2015— Steris Corporation

Name: FDA recall Z-0196-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-10

Class II · Terminated

Class II FDA medical device recall by Steris Corporation, initiated 2014-10-10, terminated 2015-06-26. It names one FDA 510(k) clearance: K090136. Product: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.. Reason: The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table. Severe damage to the shrouds may prevent the user from raising or lowering the surgical table..

Recalling firm: Steris Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-10-10
Terminated: 2015-06-26
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K090136 — STERIS CMAX XLT SURGICAL TABLESTERIS Corporation·cleared 2009-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.

Reason for recall

The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table. Severe damage to the shrouds may prevent the user from raising or lowering the surgical table.

Data sourced from openFDA. This site is unofficial and independent of the FDA.