Company: Elekta, Inc.
Date of Enforcement Report 1/6/2016
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Recall Number Z-0557-2016
Incorrect drug dosage due to “Age Limit” and patient weight data item issue..
Elekta Inc., Altanta, GA on 12/9/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE