Home / Recalls / Elekta, Inc. / Z-0182-2022

Z-0182-2022 Class II Ongoing

Recalled by Elekta, Inc. — Atlanta, GA

FDA device recall Z-0182-2022 was initiated by Elekta, Inc. on October 13, 2021 and is designated Class II. Reason for recall: Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels. The recall status is ongoing. Affected quantity: 1072 devices.

Recall Details

Product Type
Devices
Report Date
November 3, 2021
Initiation Date
October 13, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1072 devices

Product Description

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

Reason for Recall

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

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

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

Other recalls by Elekta, Inc.

  • Z-2406-2026 Class II — MOSAIQ Oncology Information System (May 21, 2026)
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  • Z-2006-2026 Class II — Brand Name: Leksell Vantage Arc System REF: 1053958 (March 19, 2026)
  • Z-1581-2026 Class II — Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfe (February 18, 2026)
  • Z-1164-2026 Class II — Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Ele (December 14, 2025)
  • Z-1340-2026 Class II — Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning (December 12, 2025)
  • Z-1339-2026 Class II — Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning (December 12, 2025)
  • Z-1078-2026 Class II — MOSAIQ Oncology Information System with Particle Therapy License (License Kit 4 (December 10, 2025)

FDA data resources