Monaco Radiation Treatment Planning System recall
Monaco Radiation Treatment Planning System (RTP) System
Why was Monaco Radiation Treatment Planning System recalled?
Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
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 Build: 5.50.00 & 5.51.00; UDI GTIN: (01)00858164002244(10) 5.50.00, (01)00858164002268(10) 5.51.00
- Product
- Monaco Radiation Treatment Planning System (RTP) System
- Recalling firm
- Elekta, Inc.
- Quantity
- 49 units
- Distribution
- Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.
- Recall date
- September 4, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)