# FDA recall Z-0182-2022

> **Elekta, Inc.** · Class II · device recall initiated 2021-10-13.

## Product

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

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

## Key facts

- **Recall number:** Z-0182-2022
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-13
- **Report date:** 2021-11-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Atlanta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0182-2022

## Citation

> AI Analytics. FDA recall Z-0182-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0182-2022. Source: US FDA. Licensed CC0.

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