Company: Elekta Inc
Date of Enforcement Report: 8/7/2019
Class II
PRODUCT
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Recall Number: Z-2091-2019
REASON
When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.
RECALLING FIRM/MANUFACTURER
Elekta Inc on 7/3/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1396 units
DISTRIBUTION
Worldwide