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.
FDA Recall Z-0221-2015 · Posted 2014-11-15
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-11-03
Date Terminated2015-07-27
Product Quantity15
Reason for Recall
A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports.
Firm Action
Elekta sent an Urgent Important Field Safety Notice letter to alert customers of the issue. This notice was distributed on November 3, 2014. A fix to the defect has been developed and has been released by Product Creation. For question call 408-830-8000.
Root Cause
Software design
Distribution Pattern
US Nationwide Distribution in the states of AZ. CO, IL, MD, MO, NY, OK, OR, PA, RI, TX, VA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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