Events

Recall of ASTRAL 150

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RESMED LIMITED.

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
    82474
  • Event Risk Class
    III
  • Event Initiated Date
    2016-08-17
  • 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
    When astral ventilators are used with the internal battery as the sole power source it is important to note that failure of the internal battery can lead to cessation of therapy without the low battery or critically low battery alarm sounding even when the battery indicates that it is charged. this could put patients at risk to not getting therapy.

Device

ASTRAL 150
  • Model / Serial
    Model Catalog: 27003 (Lot serial: manufacturer.); Model Catalog: 27003 (Lot serial: >10 serial numbers. Contact); Model Catalog: 27919 (Lot serial: >10 serial numbers. Contact); Model Catalog: 27919 (Lot serial: manufacturer.)
  • Product Description
    Astral 150;Astral External Battery
  • Manufacturer
    RESMED LIMITED

Manufacturer

RESMED LIMITED
  • Manufacturer Address
    BELLA VISTA
  • Manufacturer Parent Company (2017)
    ResMed, Inc.
  • Source
    HC