RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
This recall has been terminated (originally issued June 17, 2014).
- Recall Initiated
- April 25, 2014
- Posted
- June 17, 2014
- Terminated
- June 26, 2017
- Recall Number
- Z-1806-2014
- Quantity
- 25 sites/245 units (US), 25 sites/124 units (foreign)
- Official Source
- View on FDA website ↗
Reason for Recall
This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
Distribution
Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy, New Zealand, Republic of Korea, Switzerland, Spain, and United Kingdom.
Lot / Code Info
Software version 4.0.3.4
Root Cause
Software design
Action Taken
On April 25, 2014, RaySearch emailed all consignees of the affected product a copy of the recall notice as well as the response forms. Back up notification methods include phone calls and site visits.