Events

Recall of Monitors B20 or B40 Software version VSP-A_1.10 (or earlier) (Multiparameter Patient Monitor)

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-2012-RN-01104-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-10-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01104-1
  • 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
    The 'v tachy' and 'v fib' alarms of monitor b20 or b40 in neonatal mode are disabled due to a design issue. the user manual says that the monitor will detect these alarms.
  • Action
    Clinicians should stop using the monitors in NEONATAL mode until the sponsor provides a software solution to correct the problem.

Device

Monitors B20 or B40 Software version VSP-A_1.10 (or earlier) (Multiparameter Patient Monitor)
  • Model / Serial
    Monitors B20 or B40 Software version VSP-A_1.10 (or earlier) (Multiparameter Patient Monitor)ARTG Number: 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd