# FDA recall Z-0543-2021

> **GE Healthcare, LLC** · Class II · device recall initiated 2020-10-27.

## Product

MAC VU360, Electrocardiograph

## Reason for recall

Incorrect patient identification and/or patient demographic errors.

## Distribution

Domestic Distribution: AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,MN, MO, MS, MT, NC, NE, NH, NJ, NM,   NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.    International Distribution: AUSTRALIA, AUSTRIA, BELGIUM, Canada, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, Germany, Hong Kong, IRELAND, ISRAEL, ITALY, Korea, KUWAIT, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, QATAR, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, THAILAND, UNITED ARAB EMIRATES, United Kingdom.

## Key facts

- **Recall number:** Z-0543-2021
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-27
- **Report date:** 2020-12-16
- **Termination date:** 2024-05-03

- **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-0543-2021

## Citation

> AI Analytics. FDA recall Z-0543-2021. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-0543-2021. Source: US FDA. Licensed CC0.

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