# FDA recall Z-2060-2019

> **GE Healthcare, LLC** · Class II · device recall initiated 2019-06-28.

## Product

MAC VU360, Model Number 2030360-001, Electrocardiograph

## Reason for recall

Two issues:  1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient.      2) The MAC VU360 may have the incorrect patient demographics appear on the patient banner. This may result in the ECG report being assigned to the incorrect patient.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-2060-2019
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-28
- **Report date:** 2019-07-31
- **Termination date:** 2021-04-13

- **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-2060-2019

## Citation

> AI Analytics. FDA recall Z-2060-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2060-2019. Source: US FDA. Licensed CC0.

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