Elekta Inc: 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 r

Is my product affected?

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

• UPC 00858164002190

Check against the official notice below — it lists the full affected range.

What happened

Elekta Inc. has recalled the Monaco RTP Radiation Treatment Planning System due to a software issue affecting versions 5.40.00 and 5.40.01. The system, which is used to create treatment plans for patients receiving external beam radiation therapy, may incorrectly change the shape and volume of treatment contours, potentially causing the device to deliver an inaccurate radiation dose to patients. A total of 96 devices have been affected by this recall, which has been distributed worldwide including across multiple U.S. states (Iowa, New Jersey, New York, Pennsylvania, Texas, and Wisconsin) and numerous countries.

The recall notice does not specify a remedy or recommended course of action for affected consumers or healthcare facilities.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide Distribution in the states of IA, NJ, NY, PA, TX, WI and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, United Kingdom. Quantity: 96 devices 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)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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