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Recall Observatory FDA recall evidence

Device 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.

Z-1712-2015

May 21, 2015

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 71318
Status
Terminated
Classification
Class II
Quantity
351
Official record key
device-enforcement:Z-1712-2015

Official wording

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

Code information: MUJ/892.5050, Software Builds - 3.3, 4.0, 4.1, 4.3

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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