Monaco Radiation Treatment Planning recall
Monaco Radiation Treatment Planning (RTP) System
Why was Monaco Radiation Treatment Planning recalled?
If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.
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 version 5.40
- Product
- Monaco Radiation Treatment Planning (RTP) System
- Recalling firm
- Elekta, Inc.
- Quantity
- 14 devices
- Distribution
- Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.
- Recall date
- March 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)