Events

Recall of Carestation 620 A1, 650 A1, and 650c A1 Anaesthesia devices and service kits

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare 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-2016-RN-00143-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-02-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00143-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue with the btv switch of certain carestation 600 series anaesthesia systems. the btv switch could become difficult to move between mechanical ventilation and manual bag modes or remain in a position where it is not possible to ventilate the patient using the anaesthesia system. this issue could result in loss of patient ventilation potentially resulting in hypoxia. there have been no customer complaints or injuries reported as a result of this issue.
  • Action
    GE Healthcare is advising users that the systems can continued to be used. However users should ensure back up ventilation, independent of the anaesthesia machine is available. GE is advising users all affected devices will be corrected.

Device

Carestation 620 A1, 650 A1, and 650c A1 Anaesthesia devices and service kits
  • Model / Serial
    Carestation 620 A1, 650 A1, and 650c A1 Anaesthesia devices and service kitsSerial Numbers: Carestation 620 A1 (GTIN: 00840682103985): SM615020004WA to SM616010008WACarestation 650 A1 (GTIN: 00840682103947): SM715020005WA to SM716010008WACarestation 650c A1 (GTIN: 00840682103954): SM815020001WA to SM815500001WAService kits affected2071003-001-S , BTV SWITCH ASSEMBLY2081000-001-S , ASSY BOTTOM BC2082466-001-S, ASSY BOTTOM BC AUS FEMALE 22ARTG Number: 93955
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd