Events

Recall of Philips Brilliance iCTCT Systems with software version 4.1.6

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-01070-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01070-1
  • 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 have identified the following issues with brilliance ict s/w v4.1.61. scan parameters exceeds system resources2. scan may start at the top of the head, which may not be where the operator is expecting the scan to start3. error message appears “the exam application stopped working” & will instruct the operator to close the program4. during a bolus tracking procedure, after acquiring the surview, locator & tracker, the scanner may move into place, give patient breathing instructions, & then fail to acquire the scan5. image volumes are not found in patient directory when thin images are included in one of the multiple results6. application may fail when modifying the results plan box during 3d calcium score7. tube too hot8. memory overflow9. while the reconstruction is in progress disconnecting the recon box (cirs) may not give error message10. in the plan viewer, if the start position is modified the total length of the acquisition will change as well.
  • Action
    Philips Healthcare is notifying the affected users of these issues via this Customer Information Letter. The customers will be contacted by their local Field Service Engineer for implementation of the field correction under FC072800678 to be conducted free of charge to the customer.

Device

Philips Brilliance iCTCT Systems with software version 4.1.6
  • Model / Serial
    Philips Brilliance iCTCT Systems with software version 4.1.6Brilliance iCT SP (728311)Brilliance iCT (728306)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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