Events

Recall of STERIS 5085 and 5085SRT surgical tables

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Steris Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60305
  • Event Risk Class
    Class 2
  • Event Number
    Z-0279-2012
  • Event Initiated Date
    2011-10-17
  • Event Date Posted
    2011-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104997
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    surgical tables - Product Code FQO
  • Reason
    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.
  • Action
    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).

Device

STERIS 5085 and 5085SRT surgical tables
  • Model / Serial
    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).
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Address
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Manufacturer Parent Company (2017)
    Steris Corporation
  • Source
    USFDA