MONACO (2016-08-18)

Starting date:

August 18, 2016

Posting date:

August 26, 2016

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-59992

• Reason
• Affected products

Affected Products

MONACO

Reason

In a specific workflow where contours are edited and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner. If the patient is not saved and recalled, in a subsequently created plan the bev will show the contours as still present while the transverse, sagittal and coronal views will show the contours as deleted.  The total volume of the structure reported in the dvh and the structure control will not match. If the study set is saved and reopened before plan creation the total volume of the structure reported in the dvh and the structure control will be corrected. A similar workflow could trigger the defect if contour deletions and edits are performed while a plan is loaded.

Affected products