—#131263

Product

MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123230
Affected lot / code info: MOSAIQ Release 2.60.257

Why it was recalled

A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports.

Root cause (FDA determination)

Software design

Action the firm took

Elekta sent an Urgent Important Field Safety Notice letter to alert customers of the issue. This notice was distributed on November 3, 2014. A fix to the defect has been developed and has been released by Product Creation. For question call 408-830-8000.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution in the states of AZ. CO, IL, MD, MO, NY, OK, OR, PA, RI, TX, VA

Timeline

Recall initiated: 2014-11-03
Posted by FDA: 2014-11-15
Terminated: 2015-07-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131263. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.