RayStation software version 4.0.3.4 RayStation is a recall
RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Why was RayStation software version 4.0.3.4 RayStation is a recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software version 4.0.3.4
- Product
- RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 25 sites/245 units (US), 25 sites/124 units (foreign)
- 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.
- Recall date
- June 25, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)