Monaco Radiation Treatment Planning System recall
Monaco Radiation Treatment Planning System (RTP) System
Why was Monaco Radiation Treatment Planning System recalled?
Monaco is using the incorrect energy when optimizing and calculating dose.
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?
Software Builds: 5.40.00, 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002244(10) 5.50.00, and (01)00858164002268(10) 5.51.00
- Product
- Monaco Radiation Treatment Planning System (RTP) System
- Recalling firm
- Elekta Inc
- Quantity
- 76 (7 US, 69 OUS)
- Distribution
- IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.
- Recall date
- December 18, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)