# FDA recall Z-0113-2020

> **GE Healthcare, LLC** · Class II · device recall initiated 2019-09-03.

## Product

Achilles Express Bone Sonometer

## Reason for recall

Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.

## Distribution

Nationwide distribution to AZ, GA, MT, NC, NJ, NY, OH, WI.    International distribution to Australia, Bahrain, Bangladesh, Brazil, Cambodia, Chile, China, Colombia, Cyprus, Hong Kong, India, Iraq, Ireland, Italy, Kuwait, Lebanon, Malaysia, Mauritius, Mexico, MEXICO, Myanmar, Nepal, Oman, Panama, Peru, Philippines, Saudi Arabia, Singapore, Sri Lanka, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay, Vietnam

## Key facts

- **Recall number:** Z-0113-2020
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-03
- **Report date:** 2019-10-16
- **Termination date:** 2021-02-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0113-2020

## Citation

> AI Analytics. FDA recall Z-0113-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0113-2020. Source: US FDA. Licensed CC0.

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