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Terminated

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.

FDA Recall Z-0050-2018 · Posted None

Recalling FirmNucletron BV
Recall StatusTerminated
Product CodeMUJ
Date Initiated2017-08-10
Date Terminated2020-11-20
Product Quantity89 customer sites have the affected software

Reason for Recall

Incorrect source step size may occur in the software plans

Firm Action

Elekta sent an Field Safety Notice notification dated August 2017, and was emailed to customers on August 10, 2017, informed users of the issue and workarounds that can be used to avoid the issue.The user is informed the issue will be resolved in a fix which will be released by the end of February 2018. Once released, the firm will proactively reach out to all affected customers to arrange a time to install the fix. An acknowledgement form was enclosed which the user was to complete to indicate they have read and understood the notice and accept implementation of any given recommendations. For further questions, please call (770) 670-2359.

Root Cause

Software design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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