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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Event Detail

Event ID 63142
Product Type Devices
Status Ongoing
Recalling Firm Steris Corporation
City Mentor
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-06
Initial Firm Notification of
Consignee or Public
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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). Serial numbers from 0403809001 to 0408612102 Class II 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 unlocked when in fact the floor locks are engaged. 379 tables Z-2426-2012