Events

Safety Alert for TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace, GEMINI LXL, 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 Medical Systems.

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
    2012-11-13
  • Event Date Posted
    2012-11-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121113.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
    Medical device safety alert: philips tumorloc in brilliance ct big bore, extended brilliance workspace, gemini lxl, gemini tf 16, gemini tf 64, gemini tf big bore medical device manufacturer, philips medical systems, has issued a medical device safety alert concerning tumorloc in brilliance ct big bore, extended brilliance workspace (ebw), gemini lxl, gemini tf 16, gemini tf 64 and gemini tf big bore. the tumorloc application has the capability to generate intensity projection datasets from respiratory gated data. a circumstance has been identified where these generated datasets are flipped and incorrectly labeled left to right when they are saved to disk. this problem occurs only if all of the following circumstances are met: 1. the respiratory gated series are loaded into tumorloc along with a non-gated (free breathing) series, and 2. the data loaded into tumorloc is generated with specific patient orientations, and reconstructed with specific view conventions (see below). head first prone / right on left head first prone / view from feet feet first supine / view from bed feet first prone / view from feet if the flipped intensity projection dataset is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion. the manufacturer advised the affected users to maintain a copy of the field safety notice(fsn) with the equipment instructions for use and follow the additional instructions mentioned in the fsn until the software correction is issued. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 13 november 2012.

Device

TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace, GEMINI LXL, GEMINI TF 16, GEMI...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace, GEMINI LXL, GEMINI TF 16, GEMINI TF 64, GEMINI TF Big Bore
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH