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Terminated

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

FDA Recall Z-0447-2016 · Posted None

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2015-11-24
Date Terminated2021-09-15
Product Quantity211

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.

Firm Action

Elekta sent an Urgent Important Field Safety Notice 371-01-MSQ-004 to all affected customers on 11/24/2015. The notice informs users to the issue, the work around and the solution. The customers are instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta Office or Representative, as soon as possible but no longer than 30 days from receipt.

Root Cause

Software design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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