Recall Z-0604-2016 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
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.
| Date | Dec 18, 2015 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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 s |
| Quantity | 154 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121448 | ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY Elekta Inc. D/B/A Nucletron Corporation, Jul 2, 2012 |