Events

Recall of Barco Surgical Displays

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Barco Systems 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-2015-RN-00512-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00512-1
  • 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 surgical display types listed above could lose the user- defined settings, including failover, under the following condition:after being in stand-by mode or being in autosearch mode for at least an accumulative time of 4,152 hours (173 calendar days) and the unit is powered off and back on, or went into stand-by mode and back on. the accumulative time does not need to be continuous. one of the lost settings is the user setting for automatic failover switching.Barco has investigated this behaviour and confirms that both the failover mode and user (defined) profile settings will indeed be lost on the products involved. however, the factory settings are never lost.The behaviour is caused by a firmware issue on the barco surgical displays listed below.
  • Action
    As a short term solution Barco is recommending that end users either: - Verify the correctness of the failover mode setting in the user settings before each use; or - Disable the failover mode in the user settings of the OSD and if needed switch manually to the backup source. With this intermediate fix, the display can continue its normal operation, until the final corrective action will be implemented. Barco is currently validating a new firmware version which will fix the issue. This action has been closed-out on 22/08/2016.

Device

Barco Surgical Displays
  • Model / Serial
    Barco Surgical DisplaysSurgical Display MDSC-2224 (24 inch) Part Numbers K9307912, K9307913, K9307916 and K9307917Surgical Display MDSC-2226 (26 inch) Part Numbers K9307906, K9307907 and K9307908Surgical Display MDSC-2242 (42 inch) Part Numbers K9307914 and K9307915
  • Manufacturer
    Barco Systems Pty Ltd

Manufacturer

Barco Systems Pty Ltd
  • Manufacturer Parent Company (2017)
    Barco NV
  • Source
    DHTGA