—#130736

Product

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

FDA product code: GDC — Table, Operating-Room, Electrical
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K090136
Affected lot / code info: 5085 and 5085SRT

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

STERIS will mail Consignee Notification Letters to the affected Consignees via FedEx with tracking numbers for delivery confirmation. The Consignee Notification mailing will initiate the week of October 13, 2014.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: US distribution: AL, AZ, AR, CA, CO, CN, DC, FL, GA, HI, ID, IL, IN, IA, KN, KY, LA, ME, MD, MI, MN, MS, MO, NB, NV, NY, NC, ND, OH, OK, OR, PN, RI, SC, SD, TN, TX, VA, WV, WI. Foriegn: Austrialia, Brazil, Canada, China, Ecuador, India, Korea, Mexico, Pnama, and Thailand.

Timeline

Recall initiated: 2014-10-10
Posted by FDA: 2014-11-07
Terminated: 2015-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130736. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.