GE Healthcare recalls Signa Vibrant MRI systems with potential incorrect date recording on images due to installation workflow issues. No immediate action needed but ensure date settings are correct for accurate imaging records.
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 certain Signa Vibrant MRI systems because a potential installation issue might cause the system to record incorrect dates on medical images. This could lead to inaccurate medical records if the dates are wrong. The recall does not require immediate action but ensures proper date settings for accurate imaging.
The MRI system's date and time settings are used to record dates on medical images. If the system is installed incorrectly, it may record inaccurate dates on images, potentially leading to confusion in medical records.
Healthcare facilities using GE Healthcare's Signa Vibrant MRI systems with specific model numbers are affected. Medical staff and patients using these systems are at low risk as the issue does not cause immediate harm.
Check for the model numbers: 1.5T Signa HDx, 1.5T Signa HDxt, or Signa HDi. These systems were sold with specific serial numbers listed in the recall notice.
Ensure the MRI system's date and time settings are correct to prevent inaccurate image recording.
No, the recall does not require stopping use. Correcting the date settings is sufficient.
Incorrect dates on medical images could lead to inaccurate medical records, but this does not cause immediate harm.
Check for the model numbers: 1.5T Signa HDx, 1.5T Signa HDxt, or Signa HDi. These systems were sold with specific serial numbers listed in the recall notice.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0877-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0877-2020 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.
