Z-0670-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- November 22, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76 (7 US, 69 OUS)
Product Description
Monaco Radiation Treatment Planning System (RTP) System
Reason for Recall
Monaco is using the incorrect energy when optimizing and calculating dose.
Distribution Pattern
IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.
Code Information
Software Builds: 5.40.00, 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002244(10) 5.50.00, and (01)00858164002268(10) 5.51.00