Monaco RTP System, 5.40 Unity, 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 30 units of its Monaco RTP System, version 5.40 Unity, a radiation treatment planning system used to create treatment plans for patients receiving external beam radiation therapy. The system has a defect where forced electron density settings can be unintentionally changed for some structures, which can result in incorrect dose calculations in radiation treatment plans.
The affected units were distributed worldwide, including across the United States in Wisconsin, Ohio, New York, Indiana, Iowa, and Texas, as well as in Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, the Netherlands, Sweden, and the United Kingdom. The source document does not specify what action affected consumers should take in response to this recall.
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: 30 units Lot/code info: UDI (01)00858164002190(10) 5.40.00
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.