FDAFDA · Food and drugs·Recall number Z-0050-2018
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.
Published November 1, 2017 · Recall initiated: August 10, 2017
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
Incorrect source step size may occur in the software plans
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Nucletron BV
- Distributor
- 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.
- Lot
- Versions 4.5, 4.5.1, and 4.5.2.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
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