—#147305

Product

MOSAIQ Oncology Information System

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K141572
Affected lot / code info: Versions 2.62 and higher

Why it was recalled

It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.

Root cause (FDA determination)

Software design

Action the firm took

Elekta sent an Important Field Safety Notice to all customers on June 17, 2016. The notice informs users of the specific product and version numbers affected by the issue, and any work around that can be used to avoid the issue. A software patch will be issued for Mosaiq version 2.62 in order to the correct the defect. For further questions please call (404) 993-5886.

Recalling firm

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

Distribution

Distribution pattern: US Distribution including Puerto Rico and to the states of : AK, AZ, CA, FL, GA, IL, IN, LA, MD, MI, MO, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and to the countries of : Canada, Denmark, Finland, Germany, Israel, Japan, Netherlands, Norway, Sweden, United Kingdom

Timeline

Recall initiated: 2016-06-17
Terminated: 2020-08-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147305. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.