GE Healthcare recalls SIGNA MR380 MRI systems where accidentally clicking the Patient Orientation button instead of Save RX may cause incorrect patient imaging. Affected units may need correction to prevent misaligned 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 MR380 MRI systems because a button error can cause patient images to be incorrectly oriented. This could lead to misdiagnosis if the system misinterprets the patient's position during scans.
The system has a button that can be accidentally clicked when the user intends to save a prescription. This causes the patient's orientation to be recorded incorrectly before the initial scan, potentially flipping images and leading to misdiagnosis.
Medical facilities using SIGNA MR380 MRI systems are likely affected. Patients undergoing scans with these systems may be at risk if the imaging is misaligned.
The affected product is the SIGNA MR380 MRI system. This recall applies to units sold by GE Healthcare.
Verify that the Patient Orientation button does not accidentally activate when selecting Save RX.
GE Healthcare has identified that the Patient Orientation button may be accidentally clicked instead of Save RX, causing incorrect patient orientation during scans.
The recall states that misaligned images could lead to misdiagnosis, but no specific injuries or deaths have been reported.
The affected product is the SIGNA MR380 MRI system, which was sold by GE Healthcare.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2060-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2060-2021 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.
