Company:Elekta, Inc.
Date of Enforcement Report: 7/22/2015
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-2063-2015
REASON
A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.
RECALLING FIRM/MANUFACTURER
Elekta Inc., Altanta, GA on 7/1/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
74
DISTRIBUTION
Nationwide and Internationally
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