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Health product recall

Eclipse TPS v11.0 (2016-01-11)

Starting date:
January 11, 2016
Posting date:
January 25, 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-56826

Affected Products

Eclipse TPS v11.0

Reason

An anomaly was identified with Eclipse treatment planning system using pencil beam convolution (PBC) 11.0.31 to compute a conventional arc dose distribution. When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments with Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated monitor units (MU). All affected devices in Canada are at version 11.0.

Affected products

Eclipse TPS v11.0

Lot or serial number

none

Model or catalog number

TPC001001001

Companies
Manufacturer

Varian Medical Systems, Inc.

3100 Hansen Way

Palo Alto

94304

California

UNITED STATES