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Recall Observatory FDA recall evidence

Device product

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.

Z-1869-2014

May 29, 2014

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 68386
Status
Terminated
Classification
Class II
Quantity
101
Official record key
device-enforcement:Z-1869-2014

Official wording

Reason: 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.

Code information: Released builds 2.50.04D5 and higher

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.