Recall – Radiation treatment planning system potential for inaccurate dose

Company: Elekta Inc
Date of Enforcement Report: 5/7/2020
Class II

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.

Recall Number: Z-1803-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

Elekta Inc on 4/16/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

96 devices

DISTRIBUTION

U.S. Nationwide and International

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