MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Reported: December 23, 2015 Initiated: November 24, 2015 #Z-0447-2016
Product Description
MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Reason for Recall
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.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 211
- Distribution
- 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.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.. Recalled by Elekta, Inc.. Units affected: 211.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2015. Severity: Moderate. Recall number: Z-0447-2016.
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