Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Check against the official notice below — it lists the full affected range.
Elekta Inc. has recalled its Monaco RTP System software builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 due to a hazard in the radiation treatment planning process. If a treatment couch is removed while a treatment plan is loaded into the system and then added back to the system when the plan is unloaded, the software may calculate radiation dose with the couch unassigned to the beams, potentially resulting in an inaccurate dose calculation.
The affected software was distributed in the United States in Iowa, New Jersey, New York, Tennessee, Pennsylvania, Texas, and Wisconsin, as well as internationally in Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, the Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey, and the United Kingdom. The recall record does not specify a remedy or action that consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
Reason for recall: If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams. Distribution: Distribution in US - IA, NJ, NY, TN, PA, TX, and WI OUS distribution in Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom Quantity: N/A Lot/code info: Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10 UDI: (01)00858164002190(10) 5.40.00 (01)00858164002190(10) 5.40.01 (01)00858164002190(10) 5.40.02 (01)00858164002268(10) 5.51.10
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.