GE Healthcare recalls SIGNA MR35:5 and MR360 MRI systems where clicking the wrong button may cause flipped images. Affected units may need reconfiguration to prevent incorrect patient 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 MR355 and MR360 MRI systems because a button error can cause patient images to be flipped or mislabeled. This could lead to incorrect medical diagnoses if not fixed.
The "Patient Orientation" button can be accidentally clicked instead of the "Save RX" button. This causes the system to save a patient orientation that doesn't match their actual position, resulting in flipped or mislabeled images during scans.
Healthcare facilities using SIGNA MR355 or MR360 MRI systems are likely affected. Patients undergoing scans on these systems may be at risk if the system mislabels their orientation.
Check if your MRI system model is SIGNA MR355 or SIGNA MR360. These systems were sold by GE Healthcare for medical imaging.
Verify the "Patient Orientation" and "Save RX" buttons on your MRI system to ensure they are correctly labeled and functional.
GE Healthcare has become aware that the "Patient Orientation" button may be accidentally clicked instead of the "Save RX" button, causing patient images to be flipped or mislabeled.
Incorrect patient orientation can lead to mislabeled or flipped images, which might cause inaccurate medical diagnoses if not corrected.
The recall does not specify a remedy, so users should check button labels to ensure proper function and contact GE Healthcare for further guidance.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2059-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2059-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
