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The 5085 is a general surgical table with high patient… recallZ-0196-2015 · Steris Corporation · initiated Oct 10, 2014

Class II Terminated All recalls posted in November 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0196-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 10, 2014
Posted by the FDA
Nov 7, 2014
Recalling firm
Steris Corporation
Quantity
999
Product code
GDC
FDA submissions
K090136
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.

Product description

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

Code information (models, lots, serial numbers)

5085 and 5085SRT

Other devices under the same FDA submission

2 devices cleared under K090136 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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