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Recall Observatory FDA recall evidence

Device product

Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.

Z-0050-2018

August 10, 2017

Class II

Product summary

Firm
Nucletron BV
Event
Event 78087
Status
Terminated
Classification
Class II
Quantity
89 customer sites have the affected software
Official record key
device-enforcement:Z-0050-2018

Official wording

Reason: Incorrect source step size may occur in the software plans

Code information: Versions 4.5, 4.5.1, and 4.5.2.

Distribution pattern: Worldwide Distribution - USA (nationwide) to medical facilities, and to the countries of : Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, United Arab Emirates, and Viet Nam. There was no military/government distribution.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Incorrect source step size may occur in the software