Events

Safety Alert for TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace (EBW), GEMINI GXL 16, GEMINI TF 16, GEMINI TF 64, GEMINI TF Big Bore

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Philips Healthcare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-02-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120202a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: tumorloc in brilliance ct big bore, extended brilliance workspace (ebw), gemini gxl 16, gemini tf 16, gemini tf 64, gemini tf big bore medical device manufacturer, philips healthcare, has issued a field safety notice on their tumorloc software application in brilliance ct big bore, extended brilliance workspace (ebw), gemini gxl 16, gemini tf 16, gemini tf 64, and gemini tf big bore systems. according to the manufacturer, tumorloc will save the incorrect contour when the user saves the contour while in the edit mode, and the software does not force the user to exit the edit mode before saving. in tumorloc, when saving while a contour is in edit mode, that contour will shift to the slice corresponding to the most recently drawn contour of the last organ in the organ list. this occurs when using the save button, exit button or sendtolaser button. philips further explained that there may be a risk of unintended radiation to healthy tissue and failure to deliver radiation to target lesion. however, this is highly unlikely to occur because tumorloc does not have the capability to create treatment plans that include dose information. as confirmed by the local supplier, the affected product has been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace (EBW), GEMINI GXL 16, GEMINI TF...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace (EBW), GEMINI GXL 16, GEMINI TF 16, GEMINI TF 64, GEMINI TF Big Bore
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH