# FDA recall Z-3017-2017

> **Elekta, Inc.** · Class II · device recall initiated 2017-06-19.

## Product

iGUIDE Software 2.2     Product Usage:  Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

## Reason for recall

Incorrect PEC values.

## Distribution

Worldwide Distribution in the states of AK, CT, GA, KY, LA, MA, MD, MN, NC, NM, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA and countries of Hawaii  Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Slovenia, Spain, Sweden, Switzerland, United Kingdom, & Vietnam.

## Key facts

- **Recall number:** Z-3017-2017
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-19
- **Report date:** 2017-08-16
- **Termination date:** 2019-11-05

- **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-3017-2017

## Citation

> AI Analytics. FDA recall Z-3017-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3017-2017. Source: US FDA. Licensed CC0.

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