FDA Device

Monaco Radiation Treatment Planning System (RTP) System

Hazard

Monaco is using the incorrect energy when optimizing and calculating dose.

What You Should Do

Remedy

An Important Field Safety Notification letter is being emailed to affected customers beginning 11/22/2019. The letter identifies affected product, provides a description of the problem, and recommends user not use multiple energies within the same plan until a software fix has been applied to the device. A response form was asked to be returned. Affected customers are advised to contact local Elekta service teams for questions.

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Products

Monaco Radiation Treatment Planning System (RTP) System
Brand
Elekta Inc
UPC
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

Units Affected

76 (7 US, 69 OUS)

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