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
    18316
  • Event Risk Class
    II
  • Event Initiated Date
    2015-05-06
  • 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
    Potential hazard associated with the use of the spacelabs medical ultraview sl command module with the masimo spo2 pcba pn: 010-1636- 02.The reset sequence takes approximately 10 seconds and during this period monitoring of all parameters will be suspended. upon completion of the reset sequence all alarm limits will be reset to their site-defined default values. critical alarms for ventricular fibrillation and asystole are always enabled after the reset. if invasive pressure is being monitored labels will be reset to default values and the zero calibration will be lost. if non-invasive pressure is being monitored the automatic measurement mode will be disabled. a separate failure mode can also occur where the spo2 menu keys become unresponsive and prevent user changes to spo2 operation and alarm settings. in this state all alarm limits alarm functions and parameter monitoring continue unaffected and all alarm limits other than spo2 can still be adjusted.

Device

ULTRAVIEW SL COMMAND MODULE
  • Model / Serial
    Model Catalog: 91496 (Lot serial: > 10 lot 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