# FDA recall Z-0372-2019

> **Siemens Medical Solutions USA, Inc.** · Class II · device recall initiated 2018-10-05.

## Product

EVO Excel, Emission Computed Tomographic System, Material Number 10910501

## Reason for recall

The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A.  It should be labeled 0.55A.,

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0372-2019
- **Recalling firm:** Siemens Medical Solutions USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-05
- **Report date:** 2018-11-07
- **Termination date:** 2021-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hoffman Estates, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0372-2019

## Citation

> AI Analytics. FDA recall Z-0372-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0372-2019. Source: US FDA. Licensed CC0.

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