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
    141724
  • Event Risk Class
    III
  • Event Initiated Date
    2016-01-08
  • 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
    There have been nine complaints globally of the ventilator entering non-responsive state while connected to an external battery system which can cause a delay in treatment. this event can occur after the device is in a standby state only and does not occur during therapy. this only affects devices with astral service release 1.1 (sr1.1) software.

Device

ASTRAL 150
  • Model / Serial
    Model Catalog: 27003 (Lot serial: n/a); Model Catalog: 27073 (Lot serial: n/a)
  • Product Description
    Astral 150 - AMER Astral 150 - FRA
  • Manufacturer
    RESMED LIMITED

Manufacturer

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