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