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Recall Observatory FDA recall evidence

Device product

MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.

Z-0447-2016

November 24, 2015

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 72725
Status
Terminated
Classification
Class II
Quantity
211
Official record key
device-enforcement:Z-0447-2016

Official wording

Reason: First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking.

Code information: Versions prior to 2.60.

Distribution pattern: Nationwide Distribution -- AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, & Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking.

Field note

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