Monaco (2020-04-09)

Starting date:

April 9, 2020

Posting date:

May 15, 2020

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-73075

Last updated: 2020-05-15

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  Reason
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  Affected products

Affected Products

Monaco

Reason

When editing a contour and clicking on a coronal or sagittal slice, the 3D volume is recreated and re-sliced when it should not be.The result can be a change in contour shape and volume. Therefore, the patient anatomy might not be accurately represented. The problem can happen with reshape contour and replace contour as well as any contouring tool that will activate a contour when the user clicks on the view.

Affected products