Monaco RTP System recall
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Why was Monaco RTP System recalled?
When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11
- Product
- Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
- Recalling firm
- Elekta Inc
- Quantity
- 1396 units
- Distribution
- worldwide
- Recall date
- August 7, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)