Events

Recall of ULTRAVIEW SL BEDSIDE/CENTRAL MONITOR

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
    98367
  • Event Risk Class
    II
  • Event Initiated Date
    2011-08-05
  • 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 healthcare has identified an issue with model 91367 91369 91370 91387 & 91393 medical patient monitors equipped with the perioperative option (-d). one customer reported a safety concern over the inability to recognize the status of the monitor's audible alarms when the device has been left in the end case mode.

Device

ULTRAVIEW SL BEDSIDE/CENTRAL MONITOR
  • Model / Serial
    Model Catalog: 91387 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 91369 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 91370 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    SPACELABS MEDICAL PATIENT MONITOR 91387
  • Manufacturer
    SPACELABS HEALTHCARE (CANADA) INC.

Manufacturer

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