MOSAIQ 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 where ever radiotherapy and/or chemotherapy are prescribed.
FDA Recall Z-1869-2014 · Posted 2014-06-25
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-05-29
Date Terminated2021-07-16
Product Quantity101
Reason for Recall
MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order.
Firm Action
Elekta issued an Important Safety Notice dated May 29, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Corrective action that shall be taken:
Notify the affected customers of the issue - To be completed 06/22/2014
Follow up with the affected customers for:
Confirmation receipt of the LIN, AND
Confirmation of installation of patch for the fix- To be completed 11/30/2014
The notice includes a confirmation which is to be returned.
For further questions call (770) 670-2422.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MA, MI, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TX, VT, VA and WA,. and the countries of Australia, Canada, New Zealand and United Kingdom.
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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