Elekta, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1712-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Oncentra Brachy radiation therapy 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: May 21, 2015

Date Posted: June 10, 2015

Recall Number: Z-1712-2015

Event ID: 71318

Reason for Recall:

Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.

Status: Terminated

Product Quantity: 351

Code Information:

MUJ/892.5050, Software Builds - 3.3, 4.0, 4.1, 4.3

Distribution Pattern:

AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NC, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, WI, Argentina, Australia, Bangladesh, Belarus, Botswana, Brazil, Canada, Chile, China, Colombia, Ecuador, Egypt, Guatemala, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kosovo, Libya, Malaysia, Mexico, Morocco, Namibia, Nepal, New Zealand, Oman, Pakistan, Peru, Philippines, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Suriname, Taiwan, Thailand, Tobago, Ukraine, Venezuela, Vietnam, Zambia

Voluntary or Mandated:

Voluntary: Firm initiated