Health product recall

Monaco (2019-09-04)

Starting date:
September 4, 2019
Posting date:
October 18, 2019
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-71307



Last updated: 2019-10-18

Affected Products

Monaco

Reason

Recall of Monaco due to device calculating incorrect electron density (ED) information in specific situations. The dose

calculation is also affected.

Affected products

Monaco

Lot or serial number

Version 5.40

Version 5.50

Version 5.51

Model or catalog number

MONACO

Companies
Manufacturer

ELEKTA, INC.

13723 Riverport Drive, suite 100

Maryland Heights

63043

Missouri

UNITED STATES