FDAClass IINovember 19, 2014

The 5085 is a general surgical table with high patient recall

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

Why was The 5085 is a general surgical table with high patient 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

5085 and 5085SRT

Product
The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.
Recalling firm
Steris Corporation
Quantity
999
Distribution
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.
Recall date
November 19, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls