Device product
MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Z-0447-2016
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
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.