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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