GE Healthcare recalls SIGNA Premier MRI systems that may record inaccurate image dates due to installation workflow issues. Affected units require verification of date settings to prevent incorrect image timestamps.
It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
GE Healthcare is recalling SIGNA Premier MRI systems that could record incorrect dates on medical images due to a potential installation error. This might cause confusion in medical records but does not pose a safety risk to patients or staff.
The MRI system's date and time setting affects the DICOM header information in medical images. If the date is set incorrectly during installation, images could show inaccurate dates, potentially causing confusion in medical records.
Healthcare facilities using SIGNA Premier MRI systems with specific serial numbers are affected. Medical staff and patients using these systems may see incorrect image dates in medical records.
Check for the serial number 415723SHMR19 or lot number 33-4-1031 on the system. The SIGNA Premier MRI system was sold with these identifiers.
Check the system's date and time settings to ensure they match the current date and time.
The recall does not mention any safety risk to patients or staff. The issue only affects image date accuracy.
Look for the serial number 415723SHMR19 or lot number 33-4-1031 on your SIGNA Premier MRI system.
The recall does not require returning the system. Affected units can be checked for date settings.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0874-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0874-2020 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.
