Monaco Radiation Treatment Planning System. Used to recall
Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Why was Monaco Radiation Treatment Planning System. Used to recalled?
Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.
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 5.10.00
- Product
- Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Recalling firm
- Elekta, Inc.
- Quantity
- 154 units
- Distribution
- Worldwide Distribution -- US, including the states of CA, IN, MI, MO, TX and WI; and, the countries of Australia, Canada, Germany, Greece, India, Netherlands, New Zealand, Turkey, and the UK.
- Recall date
- October 14, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)