Oncentra Brachy radiation therapy planning software recall
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating…
Why was Oncentra Brachy radiation therapy planning software recalled?
Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.
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?
MUJ/892.5050, Software Builds - 3.3, 4.0, 4.1, 4.3
- Product
- Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating…
- Recalling firm
- Elekta, Inc.
- Quantity
- 351
- Distribution
- 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
- Recall date
- June 10, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)