Events

Recall of CareScape Patient Data Module (PDM) with software v2.6(used with CareScape Monitors B850, B650 and B450 with v2.0.7 or earlier software)

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-2017-RN-00873-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00873-1
  • 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 observed during a pre-installation checkout procedure that an impedance respiration apnea alarm could not be produced with pdm v2.6 and carescape b850 v 2.0.7 host monitor software. the pdm v2.6 has been limited to a small number of customer sites. the issue was identified in the biomed shop during check out. to date, no actual reported patient incidents of a missed apnea alarm with pdm v.2.6 have been reported.
  • Action
    GE Healthcare will correct all affected products at no cost to users. A GE Healthcare representative will contact each affected site to arrange for the correction to take place.

Device

CareScape Patient Data Module (PDM) with software v2.6(used with CareScape Monitors B850, B650 an...
  • Model / Serial
    CareScape Patient Data Module (PDM) with software v2.6(used with CareScape Monitors B850, B650 and B450 with v2.0.7 or earlier software)ARTG Number 118982
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd