Events

Recall of SPACELABS HEALTHCARE XHIBIT CENTRAL STATION

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
    20680
  • Event Risk Class
    II
  • Event Initiated Date
    2016-09-05
  • 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
    Spacelabs has received multiple reports of the xhibit central stations when used in conjunction with ultraview digital telemetry systems going offline or locking up. no one has been injured due to these issues. xhibit central stations used alone without ultraview digital telemetry systems are not affected.

Device

SPACELABS HEALTHCARE XHIBIT CENTRAL STATION
  • Model / Serial
    Model Catalog: 96102 (Lot serial: > 10 lots contact mfg); Model Catalog: 96280 (Lot serial: >10 lots contact mfg)
  • Product Description
    SPACELABS HEALTHCARE XHIBIT CENTRAL STATION;Ultraview Digital Telemetry System and Accessories
  • Manufacturer
    SPACELABS HEALTHCARE (CANADA) INC.

Manufacturer

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