Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen
Check against the official notice below — it lists the full affected range.
Elekta Inc. is recalling 49 units of the Monaco RTP System, versions 5.50 and 5.51, a radiation treatment planning system used to create treatment plans for external beam radiation therapy patients. The system has an issue where forced electron density settings for some structures can be unintentionally changed, which can result in incorrect dose calculations during treatment planning.
The affected units were distributed worldwide in the United States (specifically in Wisconsin, Ohio, New York, Indiana, Iowa, and Texas) as well as in Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, and the United Kingdom. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Reason for recall: It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation. Distribution: Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK Quantity: 49 units Lot/code info: UDI: (01)00858164002244(10) 5.50.00 (01)00858164002268(10) 5.51.00
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.