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Health product recall

MONACO

Starting date:
November 17, 2016
Posting date:
December 5, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-61282

Reason

Contours are not handled correctly if the computed tomography (CT) dataset contains slices with DICOM Z coordinates of xx.x50mm. If the CT data contain slices that occur at positions of xx.x50mm, there can be portions of the volume where there is a mismatch between the contour graphics shown on the screen and the contour data used during the optimization and calculation of dose. Unloading and reloading the patient data correct the problem.

Affected products

MONACO

Lot or serial number

Version 5.0 and higher

Model or catalog number

MONACO

Companies

Manufacturer
Elekta Business Area Software Systems Impac Medical Systems, Inc.
13723 RIVERPORT DRIVE SUITE 100
Maryland Heights
63043
Missouri
UNITED STATES