GE Healthcare recalls Discovery MR450 1.5T MRI systems where accidentally clicking the Patient Orientation button instead of Save RX may cause flipped images during 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 some Discovery MR450 1.5T MRI systems because a button error can cause images to be flipped or incorrectly labeled during scans. This could lead to misdiagnosis if the images aren't properly aligned with the patient's actual position.
The "Patient Orientation" button can be accidentally clicked instead of the "Save RX" button. This changes the patient's orientation setting before the initial scan, which may result in images being flipped or mislabeled relative to the patient's actual position.
Medical facilities using the Discovery MR450 1.5T MRI systems are affected. Patients undergoing scans with these systems may be at risk if images are misaligned.
The affected product is the Discovery MR450 1.5T MRI system. This recall applies to systems sold by GE Healthcare LLC.
Verify that the "Patient Orientation" button does not accidentally activate when selecting "Save RX" during scans.
The recall does not mention any risk of serious injury or harm to patients or staff.
The affected product is the Discovery MR450 1.5T MRI system sold by GE Healthcare LLC.
The recall does not specify a remedy or action for users.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2064-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2064-2021 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.
