Company: Elekta, Inc.
Date of Enforcement Report: 12/27/2018
Class II
PRODUCT
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
Recall Number: Z-0686-2019
REASON
If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.
RECALLING FIRM/MANUFACTURER
Elekta, Inc., Atlanta, GA on 12/4/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
551
DISTRIBUTION
Nationwide and Internationally