Lower risk Medical device recall · FDA · Published June 4, 2021

GE Healthcare SIGNA Premier MRI Scanner: Incorrect Patient Orientation Risk

GE Healthcare recalls SIGNA Premier MRI scanners where accidentally selecting patient orientation may cause flipped images. Affected units require correction to prevent misdiagnosis.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2052-2021Medical device GE Healthcare ›

Lower-risk 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.

Take action

Contact the company

Recalling firmGE Healthcare, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615

✎ GovInfoNow plain-language explainer

GE Healthcare is recalling SIGNA Premier MRI scanners because a button error can cause patient orientation to be flipped during scans. This may lead to misdiagnosed images if the system doesn't match the patient's actual position. Read more at govinfonow.com/recall/62380-ge-healthcare-signa-premier-mri-scanner-incorrect-patient-orientation-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62380-ge-healthcare-signa-premier-mri-scanner-incorrect-patient-orientation-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2052-2021

Cite this page

“GE Healthcare SIGNA Premier MRI Scanner: Incorrect Patient Orientation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62380-ge-healthcare-signa-premier-mri-scanner-incorrect-patient-orientation-risk. Based on FDA recall #Z-2052-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2052-2021%22&limit=1).

The FDA announced on June 4, 2021, that GE Healthcare LLC is recalling SIGNA Premier whole body magnetic resonance scanners because the 'Patient Orientation' button may be inadvertently clicked, potentially resulting in incorrectly annotated or flipped images. The agency classified the recall as Class II.

How to tell if you have it

Brand: GE Healthcare
Product: SIGNA Premier
Quantity: 100 devices

The hazard

GE Healthcare stated that the 'Patient Orientation' button may be clicked when intending to click 'Save RX,' changing the prescribed patient orientation before the initial scan. This error may result in incorrectly annotated and/or flipped images.

Context

GovInfoNow's records show GE Healthcare LLC has 97 other recalls on record since October 4, 2017. Recent similar recalls include the SIGNA Premier MRI Scanners recall dated February 27, 2026, regarding steel fittings, and the Centricity Universal Viewer recall dated July 15, 2022, involving inaccurate distance measurements. Other recent recalls of similar products include the AW Server 3.2 ext.6.5 recall (May 8, 2026) and the Centricity Enterprise Archive V2/V3/V4 Software Recall (July 31, 2026).

How to tell if you have this one

Check for SIGNA Premier MRI scanners from GE Healthcare. The issue affects products where the "Patient Orientation" button is clicked instead of "Save RX" during setup.

Brand
GE Healthcare
Category
Medical device

FDA recall event · 14 products

All 14 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distributions.

Recall number	Product, codes & lots	Quantity
Z-2052-2021	SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.; Not Available	100 devices
Z-2053-2021	SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.	311 devices
Z-2054-2021	SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.	460 units
Z-2055-2021	Discovery 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.	585 devices
Z-2056-2021	Discovery 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.	248 units
Z-2057-2021	SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	71 devices
Z-2058-2021	SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System	1737 devices
Z-2059-2021	SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System	242 units
Z-2060-2021	SIGNA MR380, Nuclear Magnetic Resonance Imaging System	—
Z-2061-2021	SIGNA Artist, Nuclear Magnetic Resonance Imaging System	562 devices
Z-2062-2021	SIGNA Voyager, Nuclear Magnetic Resonance Imaging System	541 devices
Z-2063-2021	Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System	1519 units
Z-2064-2021	Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System	40 units
Z-2065-2021	1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System	91 units

Based on the official FDA remedy

What to do — step by step

Check Button Functionality
Verify that the "Patient Orientation" button does not accidentally activate when selecting "Save RX" during scan setup.

How this recall unfolded

Recall timeline

FDA published this recall 47 days after the firm started it.

Jun 4, 2021Firm started the recall
Jul 12, 2021FDA classified it Class II
Jul 21, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62380-ge-healthcare-signa-premier-mri-scanner-incorrect-patient-orientation-risk">GE Healthcare SIGNA Premier MRI Scanner: Incorrect Patient Orientation Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2052-2021 (June 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2052-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.