Z-0965-2019 Class II Terminated
FDA device recall Z-0965-2019 was initiated by Elekta, Inc. on February 8, 2019 and is designated Class II. Reason for recall: If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptat… The recall status is terminated (terminated August 19, 2024). Affected quantity: 14 devices.
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2019
- Initiation Date
- February 8, 2019
- Termination Date
- August 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 devices
Product Description
Monaco Radiation Treatment Planning (RTP) System
Reason for Recall
If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.
Distribution Pattern
Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.
Code Information
Software version 5.40