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STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers:… recallZ-0279-2012 · Steris Corporation · initiated Oct 17, 2011

Terminated All recalls posted in November 2011

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

Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by their supplier with incorrect snap rings and an anomaly was present in the tilt cylinder. This error may affect the user's ability to move the table top out of the full right tilt position.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On October 17, 2011, Steris sent 'Urgent Voluntary Field Correction Notices' to their customers via Fedex with tracking numbers for delivery confirmation. The letter identifies the affected product and notifies the user/customers of the problem with the surgical tables. The notification letter goes on to inform the customers that a STERIS Service Representative will be contacting them to arrange for the field correction of the affected unit(s). This involves the replacement of the hydraulic column cylinder of each surgical table(s).

Recall details

Recall number
Z-0279-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 17, 2011
Posted by the FDA
Nov 23, 2011
Recalling firm
Steris Corporation
Quantity
167 tables were distributed - 5085=108 and 5085SRT=59
Product code
FQO
FDA submissions
K090136
Distribution
Nationwide distribution.

Product description

STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6.

Code information (models, lots, serial numbers)

Tables identified with the following Codes are subject to correction: 0401510077 to 0421411110. (Note: not all tables manufactured in this range are affected by this voluntary field correction).

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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