Events

Recall of Allura Xper R9 and Azurion R1.1 systems with the QA Basic Measurement tool

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-01162-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01162-1
  • 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
    Philips has identified when using the downscale option, the measurements performed with the allura r9 or azurion r1.1 systems (using qa basic measurement tool) will not be correctly exported to the external dicom destination. the difference between the original & exported measurements can vary, and the distance value after export is factor 1 to 4 smaller than the original. the difference will depend on the acquired image & used archive settings. if the measurement is re-performed at the external dicom destination, the result will also be incorrect unless a recalibration of the image is executed. if these exported downscaled images are used during/in preparation of a procedure, the incorrect measurement values could result in the selection of an incorrectly sized device. the same applies if a measurement is re-performed at the external dicom destination without executing a recalibration of the image.To date philips is not aware of any injuries that may have occurred due to this issue.
  • Action
    1. The Downscale option should be disabled in all Export protocols until Philips corrects this issue. 2. Distribute the notice to all users of the device. 3. Complete the supplied response form and return it to Philips. 4. The problem will be resolved by a software update, which is expected to be available by the end of 2017. 5. Philips representatives will notify users when the software update is available for installation. 6. In the interim, a similar notice will be provided along with newly manufactured devices shipped for use.

Device

Allura Xper R9 and Azurion R1.1 systems with the QA Basic Measurement tool
  • Model / Serial
    Allura Xper R9 and Azurion R1.1 systems with the QA Basic Measurement toolProduct Names: Allura Xper R9 7M20, Azurion 7M12, Azurion 7M20ARTG Number: 225815
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA