GE Healthcare recalls SIGNA Pioneer MRI scanners that may save incorrect patient orientations, leading to flipped images. Affected units were sold between 2019 and 2:00 PM EST on 2023-08-10.
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 Pioneer MRI scanners because a button error can cause patient images to be flipped or incorrectly labeled. This could lead to misdiagnosis if medical staff rely on the images without noticing the error.
The "Patient Orientation" button may accidentally activate instead of the "Save RX" button. This causes the system to save a patient orientation that doesn't match their actual position, resulting in flipped or mislabeled images during scans.
Healthcare facilities using SIGNA Pioneer MRI scanners are most at risk. Patients may be affected if their scans are misinterpreted due to incorrect image orientation.
The SIGNA Pioneer MRI scanner was sold between 2019 and 2:00 PM EST on August 10, 2023. Check if your scanner has the "Patient Orientation" and "Save RX" buttons labeled as shown in the recall notice.
Look for the "Patient Orientation" and "Save RX" buttons on your scanner. If they match the description in the recall, you may have an affected unit.
No, the recall states that incorrect images may lead to misdiagnosis, but it does not mention any risk of serious injury or death.
The recall does not provide a fix. The remedy is null, meaning no action is required beyond checking if your scanner has the described button issue.
The SIGNA Pioneer MRI scanner was sold between 2019 and 2:00 PM EST on August 10, 2023.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2054-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2054-2021 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.
