Elekta Inc: It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.

Agency Publication Date: September 25, 2019

Affected Products

Product: 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 and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment plann

UDI (01)00858164002190(10) 5.40.00

Product: Monaco RTP System, 5.50/5.51, 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 and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planni

UDI: (01)00858164002244(10) 5.50.00 (01)00858164002268(10) 5.51.00

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83692

Status: Active

Manufacturer: Elekta Inc

Manufactured In: United States

Units Affected: 2 products (30 units; 49 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

UDI (01)00858164002190(10) 5.40.00

UDI: (01)00858164002244(10) 5.50.00 (01)00858164002268(10) 5.51.00