RayStation Product Usage: is a software system designed recall
RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide…
Why was RayStation Product Usage: is a software system designed recalled?
For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.
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?
6.0.0.24 , 6.1.0.26 , 6.1.1.2 or 6.2.0.7
- Product
- RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide…
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 117 units
- Distribution
- US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.
- Recall date
- January 24, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)