Events

Recall of STERIS Caviwave Pro Ultrasonic Cleaning System (used to wash instruments and accessories prior to final disinfection and sterilisation)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-2015-RN-00323-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00323-1
  • 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
    Steris has learned through customer feedback and field service experience that should the caviwave pro ultrasonic cleaning system experience a temporary interruption in electrical power during a processing cycle, it is possible that the circulation pump or ultrasonic generator may stop functioning. the machine does not provide an alert notifying the user of this device malfunction. no injuries or adverse health outcomes have been reported due to this issue.
  • Action
    Device Technologies representative will contact customers to arrange an upgrade to correct the problem. Customers may continue to operate all Caviwave Pro Ultrasonic Cleaning System and are advised that if they experience a malfunction prior to the upgrade, the equipment in the cycle should be reprocessed. This action has been closed-out on 19/08/2016.

Device

STERIS Caviwave Pro Ultrasonic Cleaning System (used to wash instruments and accessories prior to...
  • Model / Serial
    STERIS Caviwave Pro Ultrasonic Cleaning System (used to wash instruments and accessories prior to final disinfection and sterilisation) Product codes: ST-CRP1172 and ST-CRP1172401 ARTG number: 158370
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd