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Health product recall

MONACO 5 (2016-05-18)

Starting date:
May 18, 2016
Posting date:
May 30, 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-58620

Affected products 

A. MONACO 5

Reason

When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined. This occurs when the port shape used to define or edit the MLC positions extends beyond or inside the actual jaw positions.

Affected products

A. MONACO 5

Lot or serial number

VERSIONS 5.10.00 AND HIGHER

Model or catalog number

MONACO RTP SYSTEM

Companies
Manufacturer
Elekta Business Area Software Systems Impac Medical Systems
Inc.
13723 Riverport Drive
Missouri
UNITED STATES