Monaco RTP System recall
Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with…
Why was Monaco RTP System recalled?
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
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?
UDI (01)00858164002190(10) 5.40.00
- Product
- Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with…
- Recalling firm
- Elekta Inc
- Quantity
- 30 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK
- Recall date
- October 2, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)