Elekta, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0604-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 18, 2015

Date Posted: January 13, 2016

Recall Number: Z-0604-2016

Event ID: 72869

Reason for Recall:

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.

Status: Terminated

Product Quantity: 154

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.

Voluntary or Mandated:

Voluntary: Firm initiated