Reported Nov 1, 2017 · Terminated
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation…
Nucletron BV
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nucletron BV · Waardgelder 1 · Veenendaal, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
Versions 4.54.5.1and 4.5.2
- Amount recalled
- 89 customer sites have the affected software
Where it was sold
- Nationwide
Why it was recalled
Incorrect source step size may occur in the software plans
This product could cause temporary or reversible health problems — stop using it.
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