Elekta Inc recalls Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

Recalled September 8, 2021 · FDA recall Z-2406-2021 · Elekta

Hazard

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. · FDA Class II

Units

N/A

Sold at

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

Description

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.

Product

Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

Manufacturer(s)

Elekta Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →