—#137303

Product

Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K081281, K121448
Affected lot / code info: MUJ/892.5050, Software Builds - 3.3, 4.0, 4.1, 4.3

Why it was recalled

Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.

Root cause (FDA determination)

Other

Action the firm took

Important User Notice, 806-03-BTP-001, was distributed to customers on 5/21/2015, A software patch is in development and is expected to be released end of November, 2015. Elekta service will work with customers to implement the patch on affected devices within 6 months of the patch release.

Recalling firm

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

Distribution

Distribution pattern: AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NC, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, WI, Argentina, Australia, Bangladesh, Belarus, Botswana, Brazil, Canada, Chile, China, Colombia, Ecuador, Egypt, Guatemala, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kosovo, Libya, Malaysia, Mexico, Morocco, Namibia, Nepal, New Zealand, Oman, Pakistan, Peru, Philippines, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Suriname, Taiwan, Thailand, Tobago, Ukraine, Venezuela, Vietnam, Zambia

Timeline

Recall initiated: 2015-05-21
Posted by FDA: 2015-06-04
Terminated: 2021-07-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137303. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.