GE Healthcare recalls SIGNA Artist 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 Artist MRI systems that may incorrectly flip patient images if the Patient Orientation button is accidentally clicked instead of Save RX. This could lead to misdiagnosis if the system shows the patient in the wrong position during scans.
The system may flip patient images if the Patient Orientation button is accidentally selected instead of Save RX during setup. This could cause misdiagnosis if the images don't match the patient's actual position. The risk is limited to specific button interactions during scan preparation.
Healthcare facilities using SIGNA Artist MRI systems are most affected. Patients undergoing scans with these systems could receive inaccurate images if the orientation is misconfigured.
Check if your SIGNA Artist MRI system has the Patient Orientation and Save RX buttons labeled as shown in the recall notice. The issue affects systems where these buttons are configured for the same action.
Verify if the Patient Orientation button is accidentally selected instead of Save RX during scan setup.
The recall does not mention any risk of injury, only potential for incorrect images.
Check if your SIGNA Artist MRI system has the Patient Orientation and Save RX buttons labeled as shown in the recall notice.
No, the recall does not require stopping use; users should check button configuration to avoid misconfiguration.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2061-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2061-2021 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.
