Events

Recall of ULTRAVIEW DIGITAL TELEMETRY SYSTEM AND ACCESSORIES

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
    53460
  • Event Risk Class
    II
  • Event Initiated Date
    2016-04-05
  • 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 complaints reporting an abnormally high frequency of "squelch" events on xhibit telemetry receivers (xtr) which is indicative of the loss of the telemetry data signal. in some cases the xhibit central monitor was also reported to display an "xhibit offline" error message for all patients being monitored. no one has been injured due to this issue.

Device

ULTRAVIEW DIGITAL TELEMETRY SYSTEM AND ACCESSORIES
  • Model / Serial
    Model Catalog: 96280 (Lot serial: > 10 lot numbers contact mfg)
  • Product Description
    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