Events

Recall of Servo VentilatorsProduct: Servo-n Serial Numbers range: 1240-1455 Product: Servo-u Serial Numbers range: 22611-24876

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Getinge Australia Pty Ltd.

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
    RC-2018-RN-00203-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-03-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00203-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Getinge have identified that under certain conditions, an internal communication error might prevent the safety valve to close automatically. as a consequence, ventilation will stop and a high priority alarm, as well as clinical alarms, will be triggered. getinge are aware of two instances where this issue has caused desaturation but have no reports of resulting permanent injuries.
  • Action
    Getinge will initiate an immediate update of all affected Servo ventilator units during which the firmware of an internal circuit board will be upgraded. Users will be contacted by their Getinge sales or service representative to plan for the update of the ventilator.

Device

Servo VentilatorsProduct: Servo-n Serial Numbers range: 1240-1455 Product: Servo-u Serial Numbers...
  • Model / Serial
    Servo VentilatorsProduct: Servo-n Serial Numbers range: 1240-1455Product: Servo-u Serial Numbers range: 22611-24876ARTG Numbers: 218345, 162468(Getinge Australia - Ventilator, neonatal/paediatric)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA