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Recall Observatory FDA recall evidence

Device product

Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The 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.

Z-0604-2016

December 18, 2015

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 72869
Status
Terminated
Classification
Class II
Quantity
154
Official record key
device-enforcement:Z-0604-2016

Official wording

Reason: 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.

Code information: Versions 3.3 and higher

Distribution pattern: Worldwide Distribution - US Nationwide in the states of CA, NY, PA, and the countries of Austria, Belarus, Canada, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Netherlands, Norway, Poland, South Korea, Spain, Sweden and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.