GE Healthcare recalls SIGNA Voyager MRI systems where accidentally clicking the Patient Orientation button instead of Save RX may cause flipped images. Affected units may need correction to ensure accurate 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 Voyager MRI systems because accidentally clicking the Patient Orientation button instead of Save RX can cause images to be flipped or incorrectly annotated. This could lead to misdiagnosis if not corrected.
The system has a button that can be accidentally clicked when intending to save a patient's orientation. This causes the system to use the wrong patient position for scans, potentially creating flipped images that could lead to misdiagnosis.
Healthcare facilities using SIGNA Voyager MRI systems are most at risk. Patients may be affected if scans are misinterpreted due to flipped images.
Check if your SIGNA Voyager MRI system has the Patient Orientation and Save RX buttons labeled as shown in the recall notice. The issue affects specific models sold by GE Healthcare.
Verify if your SIGNA Voyager MRI system has the Patient Orientation button and Save RX button as described in the recall notice.
GE Healthcare has become aware that the Patient Orientation button may be accidentally clicked instead of Save RX, causing incorrect patient orientation for scans.
The recall does not mention a risk of serious injury; the hazard is limited to potential misdiagnosis from flipped images.
Check if your SIGNA Voyager MRI system has the Patient Orientation and Save RX buttons labeled as described in the recall notice.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2062-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2062-2021 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.
