Recall of GEMINI TF BIG BORE PET/CT IMAGING SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS 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
    43459
  • Event Risk Class
    II
  • Event Initiated Date
    2015-07-06
  • Event Country
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Issue #1: when a single contour is saved in edit mode tumorloc does not save the contour in the correct location. the contour is saved in the location of the same slice where the last contour was drawn for the last region of interest (roi) in the roi list. a misplaced contour then results in a misplaced isocenter or incorrect field size. this occurs when using the save button exit button or sendtolaser button. issue #2: when the region of interest (roi) is displayed on the beam's eye viewer (bev) in outline mode and the roi color is changed the color is changed in the multi-planar projection (mpr) viewers but not the bev viewers. issue #3: tumor loc-created datasets are flipped and incorrectly labeled when non-gated data is loaded along with pulmonary gated data and is used to create intensity projection datasets (mip minip or avgip). if the clinician obtains a clinical intensity projection dataset in a certain manner a dataset can be generated that is flipped left to right. the resulting dataset is flipped and incorrectly labeled left-to-right when displayed in a viewer.Issue #4: duplicate region of interest (roi) or isocenter names can be created in tumor loc. this duplication is only possible when using the copy feature or manually naming a roi with the suffix " copy". this duplication can be created when creating a new isocenter or roi then creating another new isocenter or roi and naming the second isocenter or roi "firstname copy" (either manually or by clicking copy on the first isocenter or roi) where "firstname" is the name of the first isocenter or roi. if the user then selects the first isocenter or roi and clicks copy the resulting copy has the same name as the second isocenter/roi: "firstname copy".

Device

  • Model / Serial
    Model Catalog: 4598 001 18561 (Lot serial: 9224); Model Catalog: 4535 679 94741 (Lot serial: 7103)
  • Product Description
    GEMINI TF BIG BORE PET/CT IMAGING SYSTEM
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
  • Source
    HC