This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

Monaco (2014-08-18)

Starting date:
August 18, 2014
Posting date:
August 25, 2014
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-41173

Recalled Products

Monaco 

Reason

Areas that should receive no dose may be treated and areas that are supposed to be treated may receive more or less dose than they should. The Dicom exported plan and subsequent treatment delivery will not match the approved treatment plan. There is a remote probability of the issue resulting in serious adverse health consequences.

Affected products

Monaco

Lot or serial number

Version 3.2 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