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Eclipse TSP v.13, 13.5 and 13.6 (2016-02-11)
- Starting date:
- February 11, 2016
- Posting date:
- June 5, 2017
- 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-63454
Affected Products
A. Eclipse TSP v.13
B. Eclipse TSP v. 13.5
C. Eclipse TPS version 13.6
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. All affected devices in Canada are at version 11.0
Affected products
A. Eclipse TSP v.13
Lot or serial number
Not Applicable
Model or catalog number
TPC001001001
Companies
- Manufacturer
-
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES
B. Eclipse TSP v. 13.5
Lot or serial number
Not Applicable
Model or catalog number
VERSION 13
Companies
- Manufacturer
-
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES
C. Eclipse TPS version 13.6
Lot or serial number
Not Applicable
Model or catalog number
VERSION 13.5
Companies
- Manufacturer
-
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES