Monaco Radiation Treatment Planning System (RTP) System
Reported: December 18, 2019 Initiated: November 22, 2019 #Z-0670-2020
Product Description
Monaco Radiation Treatment Planning System (RTP) System
Reason for Recall
Monaco is using the incorrect energy when optimizing and calculating dose.
Details
- Recalling Firm
- Elekta Inc
- Units Affected
- 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.
- Location
- Saint Charles, MO
Frequently Asked Questions
What product was recalled? ▼
Monaco Radiation Treatment Planning System (RTP) System. Recalled by Elekta Inc. Units affected: 76 (7 US, 69 OUS).
Why was this product recalled? ▼
Monaco is using the incorrect energy when optimizing and calculating dose.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Moderate. Recall number: Z-0670-2020.
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