# FDA recall Z-1581-2026

> **Elekta, Inc.** · Class II · device recall initiated 2026-02-18.

## Product

Brand Name: Leksell Gamma Knife  Product Description: Leksell Gamma Knife¿ Perfexion  Leksell Gamma Knife¿ Icon"  Leksell Gamma Knife¿   Elekta Esprit      Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

## Reason for recall

Due to adapter not being properly aligned or locked in place.

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT,  FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.

## Key facts

- **Recall number:** Z-1581-2026
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-18
- **Report date:** 2026-03-25

- **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-1581-2026

## Citation

> AI Analytics. FDA recall Z-1581-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-1581-2026. Source: US FDA. Licensed CC0.

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