# FDA recall Z-2230-2019

> **Elekta, Inc.** · Class II · device recall initiated 2019-06-19.

## Product

iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2

## Reason for recall

Potential for iGUIDE to incorrectly monitor the 3D position.

## Distribution

Nationwide distribution to AK, AL, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT,   WA, WI.      Worldwide distribution to Algeria, Argentina, Australia, Austria, Belgium, Botswana, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-2230-2019
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-19
- **Report date:** 2019-08-21
- **Termination date:** 2024-05-06

- **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-2230-2019

## Citation

> AI Analytics. FDA recall Z-2230-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2230-2019. Source: US FDA. Licensed CC0.

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