Events

Recall of STERIS 4085 GENERAL SURGICAL TABLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STERIS CANADA INCORPORATED.

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
    22849
  • Event Risk Class
    II
  • Event Initiated Date
    2014-07-14
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Steris engineering analysis has determined the d1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. if one or more of the table floor lock feet become unlocked due to the loss of hydraulic pressure there is a potential for the table hand control to incorrectly indicate that the floor lock feet are locked.

Device

STERIS 4085 GENERAL SURGICAL TABLE
  • Model / Serial
    Model Catalog: ST01XXXX (Lot serial: 0418009043 to 0417114082)
  • Product Description
    STERIS 4085 GENERAL SURGICAL TABLE
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

STERIS CANADA INCORPORATED
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    HC