Terminated

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 Recall Z-1712-2015 · Posted 2015-06-04

Recalling FirmElekta, Inc.

Recall StatusTerminated

Product CodeMUJ

Date Initiated2015-05-21

Date Terminated2021-07-16

Product Quantity351

Reason for Recall

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

Firm Action

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.

Root Cause

Other

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121448ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHYElekta Inc. D/B/A Nucletron Corporation · 2012-07-02 K081281OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)Nucletron Corporation · 2008-05-20

Official Source

View FDA Recall →

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