PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: July 21, 2021 Initiated: June 4, 2021 #Z-2052-2021

Product Description

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.

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.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
100 devices
Distribution
Worldwide distributions.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
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.. Recalled by GE Healthcare, LLC. Units affected: 100 devices.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 21, 2021. Severity: Moderate. Recall number: Z-2052-2021.