Recall of CMAX 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
    82310
  • Event Risk Class
    II
  • Event Initiated Date
    2010-09-07
  • Event Country
  • 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 corporation has learned that cmax surigical tables may lose calibration if the table is operated only on battery power and if the table is in a low battery charge condition. this could result in the table moving into an unexpected tilt position when the "level" button is depressed on the hand control keypad. the likelihood of this event occurring is remote as the cmax surgical table opertor manual states to always connect the ac power cord to an appropriate ac receptacle as often and as long as possible with the main power switch set to on.

Device

  • Model / Serial
    Model Catalog: CMAX 110 (Lot serial: S/N: 11053 TO 15360); Model Catalog: CMAX 220 (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: P150832051 (Lot serial: S/N: 11053 TO 15360); Model Catalog: P150832JEJ (Lot serial: S/N: 11053 TO 15360); Model Catalog: CMAX 220 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: CMAX 110 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: P150832050 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: P150832051 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: P150832JEJ (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: CMAX 220 (Lot serial: S/N: 11053 TO 15360); Model Catalog: P150832050 (Lot serial: S/N: 11053 TO 15360); Model Catalog: P150832JEJ (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: P150832051 (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: P150832050 (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: CMAX 110 (Lot serial: S/N: 0428208115 TO 0417309157)
  • Product Description
    CMAX SURGICAL TABLE
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
  • Source
    HC