GE Healthcare, LLC: 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 incorrect

Agency Publication Date: July 12, 2021

Affected Products

Product: 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.

N/A

Product: SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

N/A

Product: SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System

N/A

Product: SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System

N/A

Product: SIGNA MR380, Nuclear Magnetic Resonance Imaging System

N/A

Product: SIGNA Artist, Nuclear Magnetic Resonance Imaging System

N/A

Product: SIGNA Voyager, Nuclear Magnetic Resonance Imaging System

N/A

Product: Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System

N/A

Product: Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System

N/A

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

N/A

Product: 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

Product: 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.

N/A

Product: 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.

N/A

Product: 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.

N/A

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88147

Status: Active

Manufacturer: GE Healthcare, LLC

Manufactured In: United States

Units Affected: 13 products (100 devices; 311 devices; 460 units; 585 devices; 248 units; 71 devices; 1737 devices; 242 units; 562 devices; 541 devices; 1519 units; 40 units; 91 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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