Oncentra Brachy 4.5 radiation therapy software The firm recall: Software Issue
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…
Why was Oncentra Brachy 4.5 radiation therapy software The firm recalled?
Incorrect source step size may occur in the software plans
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Versions 4.5, 4.5.1, and 4.5.2.
- 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…
- Recalling firm
- Nucletron BV
- Quantity
- 89 customer sites have the affected software
- Distribution
- 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.
- Recall date
- November 1, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)