Company: Elekta Inc
Date of Enforcement Report: 9/8/2021
Class II
PRODUCT
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Recall Number: Z-2406-2021
REASON
If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
RECALLING FIRM/MANUFACTURER
Elekta Inc on 7/26/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
NA
DISTRIBUTION
U.S. Nationwide and International