GE Healthcare recalls SIGNA PET/MR imagers where accidentally clicking the Patient Orientation button instead of Save RX may cause images to be flipped or mislabeled.
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 PET/MR medical imaging devices because a button mix-up can cause images to be flipped or mislabeled. This could lead to incorrect medical diagnoses if the images aren't properly aligned with the patient's actual position.
The system has a button that can be accidentally clicked when intending to save a patient's orientation. This causes the images to be flipped or mislabeled before the initial scan, potentially leading to incorrect medical interpretations.
Medical facilities using SIGNA PET/MR imagers are likely affected. Patients undergoing scans may be at risk if the images are mislabeled due to this issue.
Check if your SIGNA PET/MR imager has the Patient Orientation button and Save RX button. The issue affects devices sold by GE Healthcare.
Verify that the Patient Orientation button does not accidentally activate when clicking Save RX.
The recall does not mention any risk of serious injury. The issue may cause mislabeled images but not direct harm.
Check if your SIGNA PET/MR imager has the Patient Orientation button and Save RX button as described in the recall.
No, the recall does not require stopping use. The issue is a potential button mix-up that may cause mislabeled images.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2057-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2057-2021 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.
