SIGNA Voyager, Nuclear Magnetic Resonance Imaging System recallZ-2062-2021 · GE Healthcare, LLC · initiated Jun 4, 2021
Class II Open, Classified All recalls posted in July 2021
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss 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. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
Recall details
- Recall number
- Z-2062-2021
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jun 4, 2021
- Posted by the FDA
- Jul 12, 2021
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 541 devices
- Product code
- LNH
- FDA submissions
- K161567, K192426
- Distribution
- Worldwide distributions.
Product description
SIGNA Voyager, Nuclear Magnetic Resonance Imaging System
Code information (models, lots, serial numbers)
N/A
Other devices under the same FDA submission
1 device cleared under K161567, K192426 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA SIGNA VoyagerGe Healthcare(Tianjin) Company Limited · System, nuclear magnetic resonance imaging1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 88147).
- Z-2052-2021 · Open, ClassifiedSIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- Z-2053-2021 · Open, ClassifiedSIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- Z-2054-2021 · Open, ClassifiedSIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- Z-2055-2021 · Open, ClassifiedDiscovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- Z-2056-2021 · Open, ClassifiedDiscovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- Z-2057-2021 · Open, ClassifiedSIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
- Z-2058-2021 · Open, ClassifiedSIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
- Z-2059-2021 · Open, ClassifiedSIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System
- Z-2061-2021 · Open, ClassifiedSIGNA Artist, Nuclear Magnetic Resonance Imaging System
- Z-2063-2021 · Open, ClassifiedOptima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
- Z-2064-2021 · Open, ClassifiedDiscovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
- Z-2065-2021 · Open, Classified1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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