medical Class II Updated 2020-05-06

Elekta Inc recalls Elekta MONACO RTP Sytem, radiation treatment planning softwa

Recalled Product

Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The


Hazard / Issue

The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software Build: 5.40.00 (UDI: (01)00858164002190(10) 5.40.00), 5.40.01 (UDI: 01)00858164002190(10) 5.40.01)
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