Monaco Radiation Treatment Planning (RTP) System
Reported: March 6, 2019 Initiated: February 8, 2019 #Z-0965-2019
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.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 14 devices
- Distribution
- Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
Monaco Radiation Treatment Planning (RTP) System. Recalled by Elekta, Inc.. Units affected: 14 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2019. Severity: Moderate. Recall number: Z-0965-2019.
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