GE Healthcare recalls 1.5T SIGNA HDxt MRI systems where accidentally clicking the Patient Orientation button instead of Save RX may cause flipped images during scans. Affected units require correction to prevent misdiagnosis.
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 certain 1.5T SIGNA HDxt MRI systems because accidentally clicking the 'Patient Orientation' button instead of 'Save RX' can cause images to be flipped or mislabeled. This could lead to incorrect medical diagnoses if not fixed.
The 'Patient Orientation' button may be accidentally pressed when users intend to click 'Save RX'. This changes the patient's orientation settings before the initial scan, potentially flipping images and causing misdiagnosis. The risk is limited to specific button interactions during scan setup.
Medical facilities using the affected 1.5T SIGNA HDxt MRI systems are most at risk. Patients undergoing scans on these systems could receive misdiagnosed results if the orientation issue occurs.
Check for the 1.5T SIGNA HDxt (HD28) MRI system model. The recall applies to systems sold by GE Healthcare LLC. No specific purchase date is mentioned in the recall.
Verify that the 'Patient Orientation' button does not accidentally activate when clicking 'Save RX' during scan setup.
The recall does not mention any risk of injury; it only addresses potential misdiagnosis from flipped images.
The affected units are the 1.5T SIGNA HDxt (HD28) MRI systems sold by GE Healthcare LLC. No specific purchase date is listed in the recall.
The recall does not require immediate discontinuation; users can continue using the system with caution by checking button functionality.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2065-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2065-2021 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.
