GE Healthcare recalls SIGNA Architect MRI scanners where accidentally clicking the Patient Orientation button instead of Save RX may cause flipped or mislabeled images during scans.
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 Architect MRI scanners because accidentally clicking the Patient Orientation button instead of Save RX can cause images to be flipped or mislabeled. This could lead to incorrect medical interpretations if the images are used for diagnosis.
The Patient Orientation button may be accidentally clicked instead of Save RX during setup. This changes the patient's orientation settings before the initial scan, which can cause images to be flipped or mislabeled. Incorrect images might lead to wrong medical interpretations if used for diagnosis.
Medical facilities using SIGNA Architect MRI scanners are likely affected. Patients undergoing scans with these machines could be at risk if the images are misinterpreted.
The SIGNA Architect MRI scanner is a whole-body magnetic resonance scanner designed for high resolution imaging. The issue occurs when the Patient Orientation button is clicked instead of Save RX during setup.
Ensure the Patient Orientation button is not accidentally clicked when selecting Save RX during setup.
GE Healthcare has become aware that the Patient Orientation button may be accidentally clicked instead of Save RX, causing images to be flipped or mislabeled.
Incorrect images could lead to wrong medical interpretations if used for diagnosis, but the risk is low as the issue occurs during setup and not during the scan itself.
The official recall does not provide a fix; users should check button functionality during setup to avoid accidental clicks.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2053-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2053-2021 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.
