Events

Recall of STERIS CMAX SURGICAL TABLE HAND CONTROLS

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
    145854
  • Event Risk Class
    III
  • Event Initiated Date
    2009-05-22
  • 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
    A limited quantity of the cmax hand controls were manufactured without loctite thread locker on the screws that attach the mounting clip to the hand control case. it is possible that screws without the loctite can work loose and the clip can become separated from the hand control. if both screws back out completely the internal components of the hand control and/or the table control board may become damaged. this could cause a loss of hand functionality.

Device

STERIS CMAX SURGICAL TABLE HAND CONTROLS
  • Model / Serial
    Model Catalog: P150832-500 (Lot serial: AC001 TO AC0221)
  • Product Description
    STERIS CMAX SURGICAL TABLE HAND CONTROL
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

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