# FDA recall Z-1665-2023

> **Elekta, Inc.** · Class II · device recall initiated 2023-05-05.

## Product

Elekta Medical Linear Accelerator (ELMA) included in the below platforms:     a. Elekta Infinity;   b. Versa HD;   c. Elekta Synergy

## Reason for recall

A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601

## Distribution

Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA.  International distribution to Belgium, Canada, Chile, China, France, Germany, India, Iraq, Italy, Jordan, Libyan Arab Jamahiriya, Mauritius, Mexico, Morocco, Poland, Russian Federation, Spain.

## Key facts

- **Recall number:** Z-1665-2023
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-05
- **Report date:** 2023-06-07

- **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-1665-2023

## Citation

> AI Analytics. FDA recall Z-1665-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1665-2023. Source: US FDA. Licensed CC0.

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