RayStation Radiation Therapy Treatment Planning System recall: Software Issue
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis…
Why was RayStation Radiation Therapy Treatment Planning System recalled?
Potential for dose errors due to software program errors.
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?
MODEL #(s): 2.5, 3.0, 3.5 and 4.0; VERSIONS: 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9
- Product
- RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis…
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 151 units Total (88 units domestically & 63 units internationally)
- Distribution
- Worldwide Distribution - US including the states of NY, OH, MD, CT, CO, TN, IL, AZ, MS, NJ, PA, DE, FL, CA and WA., and the countries of New Zealand, Australia, Republic of Korea, China, Italy, Germany, Norway, Belgium, Switzerland, United Kingdom and Spain.
- Recall date
- April 9, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)