—#142037

Product

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

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K141572
Affected lot / code info: Versions prior to 2.60.

Why it was 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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

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.

Timeline

Recall initiated: 2015-11-24
Terminated: 2021-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142037. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.