FDA Enforcement Class II Terminated

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).

Recall: Z-2426-2012 · Reported September 26, 2012

Enforcement

Recall Number
Z-2426-2012
Event ID
63142
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Steris Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
September 26, 2012
Initiation Date
April 6, 2012
Classification Date
September 20, 2012
Termination Date
September 4, 2013
Address
5960 Heisley Rd, Mentor, OH, 44060-1834, United States

Description

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).

Reason

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

Code Info

Serial numbers from 0403809001 to 0408612102

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.

Quantity

379 tables