Radiation Therapy Treatment Planning System Product recall
Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation…
Why was Radiation Therapy Treatment Planning System Product recalled?
An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with the same Frame of Reference as the displayed auxiliary CT set exists in another case, the dose display may be incorrect. When the error occurs, the display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect. The dose value normally displayed in the upper left corner when pointing in the 2D view may be incorrect or missing.
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?
Build No: "5.0.0.37 , 5.0.1.11 or 5.0.2.35 . Only 5.0.2.35 was distributed in the U.S.
- Product
- Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation…
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 540 units
- Distribution
- US Nationwide Distribution in the states of AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, MA, MD, MN, MI, MS, MO, NJ, NY, NC, OH, PA, RI, TX & WA
- Recall date
- December 14, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)