Z-2409-2019 Class II Terminated
FDA device recall Z-2409-2019 was initiated by Elekta, Inc. on August 23, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated June 28, 2024). Affected quantity: 49 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2019
- Initiation Date
- August 23, 2019
- Termination Date
- June 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 units
Product Description
Monaco Radiation Treatment Planning System (RTP) System
Reason for Recall
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.
Distribution Pattern
Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.
Code Information
Software Build: 5.50.00 & 5.51.00; UDI GTIN: (01)00858164002244(10) 5.50.00, (01)00858164002268(10) 5.51.00