Company: Elekta, Inc..
Date of Enforcement Report 11/26/2014
Class lI:
PRODUCT
MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Recall Number Z-0221-2015
REASON
A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports..
RECALLING FIRM/MANUFACTURER
Elekta, Inc., Atlanta, GA 11/3/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
15
DISTRIBUTION
Nationwide
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