GE Healthcare recalls Optima MR450w 1.5T MRI systems where accidentally clicking 'Patient Orientation' instead of 'Save RX' may cause incorrect patient imaging.
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 Optima MR450w 1.5T MRI systems because a button error could cause images to be flipped or mislabeled. This might lead to incorrect medical diagnoses if the system is used without proper patient positioning.
The system has a button that can be accidentally clicked when intending to select 'Save RX'. This changes the patient's orientation settings before the initial scan, potentially flipping or mislabeling images. Incorrect images could lead to wrong medical interpretations.
Medical facilities using the Optima MR450w 1.5T MRI systems are likely affected. Staff and patients at these facilities face the lowest risk of incorrect imaging due to the button error.
Check for the Optima MR450w 1.5T model in GE Healthcare's MRI systems. The issue affects systems where the 'Patient Orientation' button is clicked instead of 'Save RX' during setup.
Ensure the 'Patient Orientation' button is not accidentally selected when intending to click 'Save RX' during setup.
Accidentally selecting 'Patient Orientation' instead of 'Save RX' changes the patient's orientation settings before the scan, which may cause images to be flipped or mislabeled.
The affected systems are GE Healthcare's Optima MR450w 1.5T MRI units where the 'Patient Orientation' button might be clicked instead of 'Save RX' during setup.
Review button functionality to ensure 'Save RX' is selected instead of 'Patient Orientation' during setup. No immediate action is required beyond this check.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2063-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2063-2021 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.
