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Health product recall

Aria Radiation Oncology Software (Version 6.5) and Eclipse Treatment Planning System (2013-11-18)

Starting date:
November 18, 2013
Posting date:
January 13, 2014
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-37473

Recalled Products

  1. Aria Radiation Oncology Software (Version 6.5)
  2. Eclipse Treatment Planning System

Reason

An anomaly has been identifed with the plan parameters workspace within Eclipse Treatment Planning System, Aria Radiation Oncology, Aria Radiation Therapy management and acuity.  When a dose relevant parameter is changed and "do not clear MUS and reference point dose" is selected, the monitor units (MU) may change. This issue does not affect Brachyvision.

Affected products

A. Aria Radiation Oncology Software (Version 6.5)

Lot or serial number
  • HIT0854R1
  • HIT1076M
  • HIT1076R1
  • HIT1076R2
  • HIT1076R3
  • HIT1076R4
  • HIT1076R5
Model or catalog number
  • VISION (Version 6.5)
  • TPC001001001
Companies
Manufacturer
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES

B. Eclipse Treatment Planning System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • VISION (Version 6.5)
  • TPC001001001
Companies
Manufacturer
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES

Date modified: