Elekta, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0182-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00

Product Classification:

Class II

Date Initiated: October 13, 2021

Date Posted: November 3, 2021

Recall Number: Z-0182-2022

Event ID: 88860

Reason for Recall:

Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.

Status: Ongoing

Product Quantity: 1072 devices

Code Information:

Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 GTIN Numbers: 08717213052758, 08717213038660, 08717213020610, 08717213052321, 08717213052314, 08717213052307, 08717213052291, 08717213052246, 08717213052239, 08717213051881, 08717213051843, 08717213051782, 08717213051775, 08717213051294, 08717213020610, 08717213053717, 08717213053700

Distribution Pattern:

Distribution throughout USA OUS distribution including:Algeria, Argentina, Australia, Austria Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran (Islamic Republic of), Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated