Health product recall

Monaco RTP System (2019-07-01)

Starting date:
July 1, 2019
Posting date:
July 19, 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-70457

Last updated: 2019-07-19

Affected Products

Monaco RTP System

Reason

Monitor units can be incorrect when following a specific workflow in MONACO. When creating 3D plans using either MU or dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the monitor units are scaled incorrectly.

Affected products

Monaco RTP System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

MONACO RTP SYSTEM

Companies
Manufacturer

Elekta INC.

13723 RIVERPORT DRIVE,, SUITE 100

Maryland Heights

63043

Missouri

UNITED STATES