—#142386

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.

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K121448
Affected lot / code info: Versions 3.3 and higher

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.

Root cause (FDA determination)

Software design

Action the firm took

Elekta sent an Important Field Safety Notice 806-01-ETP-001 to all affected customers on December 18, 2015. The notice informs users of the issue and that should the issue occur it could result in overdosage of organs at risk outside the intended treatment volume. Users are strongly advised to perform proper Quality Assurance for all treatment plans before delivery of the first fraction to the patient. To prevent the issue from occurring, the workaround is to not use the Tumor Overlap Fraction for VMAT planning.and not to use the Tumor Overlap Fraction for VMAT planning. The issue will be solved in Oncentra External Beam version 4.5.2. The notice included an acknowledgement form which is to be returned to Elekta. For questions contact your local Elekta representative.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

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.

Timeline

Recall initiated: 2015-12-18
Terminated: 2021-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142386. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.