Events

Recall of ULTRAVIEW SL COMMAND MODULE

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

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
    65583
  • Event Risk Class
    III
  • Event Initiated Date
    2011-12-21
  • 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
    The nibp pump inside of the module may come loose from its secured location and become suspended by the air hoses and electrical wiring. should this occur you may hear an unusual "rattling" noise coming from the module during anon-invasive blood pressure measurement or when the module is being handled or moved. in rare cases the module may cease to function. there have been no injuries associated with this issue.

Device

ULTRAVIEW SL COMMAND MODULE
  • Model / Serial
    Model Catalog: 91496 (Lot serial: >100 numbers contact mfg)
  • Product Description
    Ultraview SL Command Module
  • Manufacturer
    SPACELABS HEALTHCARE (CANADA) INC.

Manufacturer

SPACELABS HEALTHCARE (CANADA) INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    HC