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STERIS 5085 and 5085 SRT Surgical Tables recallZ-2426-2012 · Steris Corporation · initiated Apr 6, 2012

Class II Terminated All recalls posted in September 2012

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

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

FDA root cause category: Device Design

What the company is doing

Steris sent an Urgent Voluntary Field Correction Notice dated April 6, 2012 to all affected customer. The letter identified the affected product, description of the problem and actions to be taken. Customers were informed that a STERIS Service Representative will contact affected facility to arrange for the replacement of the stainless steel shroud covering the hydraulic column and relocation of the floor lock pressure switches on their 5085 and/or 5085SRT table(s). For further information or if you have questions regarding the visit to your facility, contact STERIS Field Service Dispatch at 1-800-333-8828. If you have questions regarding this matter, call the Director of Marketing Tables and Case Goods at 440-392-7148 or STERIS Customer Service at 1-800-548-4873.

Recall details

Recall number
Z-2426-2012
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 6, 2012
Posted by the FDA
Sep 20, 2012
Recalling firm
Steris Corporation
Quantity
379 tables
Product code
GDC
FDA submissions
K090136
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.

Product 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).

Code information (models, lots, serial numbers)

Serial numbers from 0403809001 to 0408612102

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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