GE Healthcare recalls Signa 1.5T TwinSpeed MRI systems due to potential left-right image flips. Affected units have specific system IDs listed in the recall notice.
There is potential for the images to be flipped left to right.
GE Healthcare is recalling certain Signa 1.5T TwinSpeed MRI systems because images may be flipped left to right. This could cause misdiagnosis if the images are used for medical decisions.
The MRI system may produce images that are reversed left to right. This could lead to incorrect medical interpretations if the images are used for diagnosis or treatment planning.
Medical facilities using the recalled Signa 1.5T TwinSpeed MRI systems are affected. Patients receiving scans on these systems may be at risk of misdiagnosis.
Check the system ID on your Signa 1.5T TwinSpeed MRI. Affected units have specific system IDs listed in the recall notice: MMIMR01, 213748HDMR, 714125MR, 561218MR1, 918523MR1, 304766MR1, 082427030026, 082427080007, 082427020017, 376569401MR.
Identify your Signa 1.5T TwinSpeed MRI system's ID to see if it matches the listed affected IDs.
The system may produce images that are flipped left to right, which could lead to misdiagnosis.
Check the system ID against the list of affected IDs provided in the recall notice.
The recall notice does not mention a fix or remedy for this issue.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0857-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0857-2022 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.