Radiation Therapy Treatment Planning System recall
Radiation Therapy Treatment Planning System, Model 5.0
Why was Radiation Therapy Treatment Planning System recalled?
For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.
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?
5.0.0.37, 5.0.1.11 and 5.0.2.35
- Product
- Radiation Therapy Treatment Planning System, Model 5.0
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 491 units (187 domestically & 304 internationally)
- Distribution
- AZ, CA, FL, MT, NC NY, TX, OH & WA
- Recall date
- October 19, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)