# FDA recall Z-0234-2018

> **Elekta Inc** · Class II · device recall initiated 2017-09-01.

## Product

Elekta ERGO++    Product Usage:  ERGO is often used for stereotactic treatments.

## Reason for recall

Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.

## Distribution

Worldwide Distribution - US Nationwide in the states of:  VA, CA, TX, MO, NY, WA, NM, MA, FL, CT, OK, SC, MS, NY, GA, NC and the countries of:    AUSTRALIA, BANGLADESH, BRAZIL, BULGARIA, CANADA, COLOMBIA, CZECH REPUBLIC, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ITALY, JAPAN, JORDAN, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, PERU, PHILIPPINES, PORTUGAL, RUSSIA,   SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, TAIWAN, THAILAND, TURKEY, VENEZUELA, and VIETNAM

## Key facts

- **Recall number:** Z-0234-2018
- **Recalling firm:** Elekta Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-01
- **Report date:** 2017-12-20
- **Termination date:** 2019-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maryland Heights, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0234-2018

## Citation

> AI Analytics. FDA recall Z-0234-2018. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0234-2018. Source: US FDA. Licensed CC0.

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