Events

Recall of Xhibit Central Station, software version 1.1.5

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ecomed 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-01459-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-11-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01459-1
  • 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
    Reports have been received of telemetry spo2 numerics dropping off the xhibit central display when using software version 1.1.5 with connectivity to telemetry. desaturation, high, and low limit alarms work normally. this problem can occur when the xhibit central station software version 1.1.5 is used in conjunction with a telemetry receiver for purposes of remote patient monitoring.Ecomed pty ltd has not supplied any telemetry receiver medical devices to the australian hospitals that are connected to software version 1.1.5 of xhibit central station.
  • Action
    Although there is no product affected in Australia, product correction is being undertaken by Ecomed Pty Ltd to support potential future use of telemetry functionality with the Xhibit Central System in relevant Australian hospitals. Ecomed will be contacting affected customers to perform a software update. This action has been closed-out 11/05/2017.

Device

Xhibit Central Station, software version 1.1.5
  • Model / Serial
    Xhibit Central Station, software version 1.1.5Serial Numbers: SLA1015F00831, SLA0916F02109ARTG Number: 237776
  • Manufacturer
    Ecomed Pty Ltd

Manufacturer

Ecomed Pty Ltd