GE Healthcare recalls SIGNA Premier MRI scanners where accidentally selecting patient orientation may cause flipped images. Affected units require correction to prevent misdiagnosis.
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.
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.
The "Patient Orientation" button can be accidentally clicked instead of "Save RX". This changes the patient's orientation setting before the scan starts. If the system doesn't match the patient's actual position, images may be flipped or incorrectly annotated.
Healthcare facilities using SIGNA Premier MRI scanners are affected. Patients undergoing scans with these machines may be at risk if the orientation error occurs.
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.
Verify that the "Patient Orientation" button does not accidentally activate when selecting "Save RX" during scan setup.
GE Healthcare has identified that the "Patient Orientation" button may be accidentally clicked instead of "Save RX" during scan setup, causing orientation errors.
Patients may receive misdiagnosed images if the system's orientation setting doesn't match their actual position during the scan.
Check if your SIGNA Premier MRI scanner has the "Patient Orientation" button accidentally activating when selecting "Save RX" during setup.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2052-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2052-2021 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
