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 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
    32245
  • Event Risk Class
    II
  • Event Initiated Date
    2007-01-12
  • 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
    Reports of modules resetting alarms returning to default settings invasive pressure losingits labels and zero calibration and spo2 alarm limits being frozen all of these can result in a delay in treatment.

Device

ULTRAVIEW SL COMMAND MODULE
  • Model / Serial
    Model Catalog: 91496 (Lot serial: 1496-010607); Model Catalog: 91496 (Lot serial: 1496-007758 to -007765); Model Catalog: 91496 (Lot serial: 1496-007410); Model Catalog: 91496 (Lot serial: 1496-007314 to -007317); Model Catalog: 91496 (Lot serial: 1496-007307); Model Catalog: 91496 (Lot serial: 1496-004176); Model Catalog: 91496 (Lot serial: 1496-007213 to -007225); Model Catalog: 91496 (Lot serial: 1496-006545); Model Catalog: 91496 (Lot serial: 1496-005018); Model Catalog: 91496 (Lot serial: 1496-005014 t0 -005015); Model Catalog: 91496 (Lot serial: 1496-007263 to -007278)
  • Product Description
    ULTRAVIEW SL COMMAND MODULE
  • Manufacturer
    SPACELABS HEALTHCARE INC.

Manufacturer

SPACELABS HEALTHCARE INC.
  • Manufacturer Address
    SNOQUALMIE
  • Source
    HC