Events

Recall of MEDICAL GRADE FLAT PANEL DISPLAY WITH TOUCHSCREEN

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
    55953
  • Event Risk Class
    II
  • Event Initiated Date
    2009-10-30
  • 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 potential safety hazard associated with the use of spacelabs medical 19" flat panel displays model 94260-19. there is a possibility that the internal power distribution circuit board will fail prematurely causing the display to go blank. audio alarms will continue to function normally.

Device

MEDICAL GRADE FLAT PANEL DISPLAY WITH TOUCHSCREEN
  • Model / Serial
    10 numbers contact mfg")" v-b-tooltip> Model Catalog: 94260-19 (Lot serial: ">10 numbers contact mfg")
  • Product Description
    MEDICAL GRADE FLAT PANEL DISPLAY
  • Manufacturer
    SPACELABS HEALTHCARE (CANADA) INC.

Manufacturer

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