Monaco Radiation Treatment Planning System (RTP) System
Check against the official notice below — it lists the full affected range.
Elekta Inc. has recalled its Monaco Radiation Treatment Planning System (RTP) due to a defect in which the software uses incorrect energy settings when optimizing and calculating radiation doses for treatment. The affected software includes builds 5.40.00, 5.50.00, and 5.51.00. A total of 76 systems have been distributed—7 in the United States (in Iowa, Indiana, New York, Ohio, Texas, and Wisconsin) and 69 internationally (in Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, the Netherlands, Sweden, Switzerland, and the United Kingdom).
The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Monaco is using the incorrect energy when optimizing and calculating dose.
Reason for recall: Monaco is using the incorrect energy when optimizing and calculating dose. Distribution: IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom. Quantity: 76 (7 US, 69 OUS) Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.