Reported Jan 13, 2016 · Terminated
Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation…
Elekta, Inc.
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: Elekta, Inc. · 400 Perimeter Center Ter NE Ste 50 · Atlanta, GA · 30346-1227
Is this the product you have?
- Oncentra External Beam - VMAT - Radiation
- therapy planning system Product UsageThe Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer
- Lot codes and dates
- Versions 3.3 and higher
- Amount recalled
- 154
Where it was sold
Why it was recalled
When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target volume.
This product could cause temporary or reversible health problems — stop using it.
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