FDAFDA · Food and drugs·Recall number Z-0987-2017
Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
Published January 18, 2017 · Recall initiated: December 23, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Cross profile for Varian 60 degree wedge shows "horns."
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- Worldwide Distribution - US Nationwide in the states of AL, CA, DC, NE, NY, ND, OR, PA, RI, SC, TX, and the countries of Angola, Argentina, Armenia, Australia, Austria, Barbados, Belarus, Brazil, Bulgaria, Canada, China Columbia, Curacao, Czech Republic, Denmark, Finland, France, Germany, Greece, Honduras, Hungary, Iceland, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Kenya, Malaysia, Netherlands, Norway, Oman, Peru, Poland, Portugal, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Yemen, Zambia.
- Lot
- All software builds
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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