GEMINI TF PET/CT IMAGING SYSTEM (2015-07-01)

Starting date:

July 1, 2015

Posting date:

July 21, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-54320

• Reason
• Affected products

Affected Products

1. GEMINI TF 64 PET/CT SYSTEM - MAIN UNIT
2. GEMINI TF BIG BORE PET/CT IMAGING SYSTEM

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 send to laser 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: TumorLoc 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 TumorLoc. 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) "first name copy" (either manually or by clicking copy on the first Isocenter or (ROI), where "first name" 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: "first name copy".

Affected products