Company: Elekta, Inc.
Date of Enforcement Report 1/6/2016
Class lI:
PRODUCT
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
REASON
Incorrect drug dosage due to “Age Limit” and patient weight data item issue..
RECALLING FIRM/MANUFACTURER
Elekta Inc., Altanta, GA on 12/9/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
399
DISTRIBUTION
Worldwide
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