RayStation 4.7 recall
RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment…
Why was RayStation 4.7 recalled?
Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.
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 build numbers are 4.7.1.10
- Product
- RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment…
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 126 programs
- Distribution
- Distributed in CO, IL, MI, NC, OH,TN, and WA.
- Recall date
- September 2, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)