Z-0670-2020 Class II Ongoing
FDA device recall Z-0670-2020 was initiated by Elekta Inc on November 22, 2019 and is designated Class II. Reason for recall: Monaco is using the incorrect energy when optimizing and calculating dose. The recall status is ongoing. Affected quantity: 76 (7 US, 69 OUS).
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