Events

Recall of STERIS 5085 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
    21092
  • Event Risk Class
    II
  • Event Initiated Date
    2014-10-10
  • 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 has learned through customer feedback and field service experience that the shroud cover for the hydraulic column may become misaligned and damaged as a result of extreme table articulation or excessive pressure on the side or base of the table. in most instances the shroud damage is minor and does not affect the vertical up/down movement of the hydraulic column. in cases of severe shroud damage the shroud sections may become misaligned such that vertical movement of the hydraulic column is impeded.

Device

STERIS 5085 SURGICAL TABLE
  • Model / Serial
    Model Catalog: ST01-410-X (Lot serial: 0403809001 to 0425514019); Model Catalog: STO1-420-X (Lot serial: 0403809001 to 0425514019)
  • Product Description
    STERIS 5085 SURGICAL TABLE
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

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