Events

Recall of TruVidia Wireless Receiver

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Trumpf Med Aust 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-2018-RN-00075-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00075-1
  • 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
    Trumpf medical discovered that the radiated emission from the truvidia wireless receiver is above the normative accepted limits. it is unlikely, but possible, that the radiated emission may interact with other devices in the operating room, which may cause other devices to not function properly. the frequency of interference and associated risk will be dependent upon the immunity of the other devices for radiated emissions and nature of the failure mode of the operating room equipment being used at the time.
  • Action
    Trumpf Medical is advising users that an upgrade of the affected components will be completed as a permanent correction. If users suspect that the device may be interacting with other devices in the operating room, switch off the wireless receiver (ensure the receiver is switched off, it is not sufficient to switch off the camera or control unit).

Device

TruVidia Wireless Receiver
  • Model / Serial
    TruVidia Wireless Receiver Model Number: 1940747Serial Number: 102584474 to 103214022ARTG Number 274674
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd