# FDA recall Z-2065-2021

> **GE Healthcare, LLC** · Class II · device recall initiated 2021-06-04.

## Product

1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System

## Reason for recall

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button.  This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.)  Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

## Distribution

Worldwide distributions.

## Key facts

- **Recall number:** Z-2065-2021
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-04
- **Report date:** 2021-07-21

- **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-2065-2021

## Citation

> AI Analytics. FDA recall Z-2065-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-2065-2021. Source: US FDA. Licensed CC0.

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