# FDA recall Z-0875-2020

> **GE Healthcare, LLC** · Class II · device recall initiated 2019-12-23.

## Product

SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

## Reason for recall

It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.

## Distribution

Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

## Key facts

- **Recall number:** Z-0875-2020
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-23
- **Report date:** 2020-02-05
- **Termination date:** 2020-12-11

- **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-0875-2020

## Citation

> AI Analytics. FDA recall Z-0875-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0875-2020. Source: US FDA. Licensed CC0.

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