GE Healthcare recalls SIGNA Pioneer MRI systems with potential incorrect date settings, risking inaccurate image timestamps. Affected units may need verification and correction to ensure proper medical 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 SIGNA Pioneer MRI scanners that could have incorrect date settings. This might lead to inaccurate medical images being recorded with wrong dates, which could affect patient care and medical records.
The MRI system's date and time setting can be incorrect due to installation workflow issues. This error affects the DICOM header information on medical images, potentially recording the wrong date on images. While this doesn't cause immediate harm, it could lead to inaccurate medical records and affect patient care.
Medical facilities using SIGNA Pioneer MRI scanners are likely affected. Patients and healthcare providers who rely on these systems for imaging may be impacted if the date issue affects medical records.
Check for the system ID numbers listed in the recall notice, such as GON4833100, 01264, 860536MR3T, KZTBL1700064TJ, and other serial numbers provided in the recall document.
Check the system ID numbers on your SIGNA Pioneer MRI scanner, such as GON4833100, 01264, 860536MR3T, or KZTBL1700064TJ.
The recall is due to a potential installation workflow issue that could cause the MRI system's date and time setting to be incorrect, leading to inaccurate dates on medical images.
Incorrect dates on medical images could lead to inaccurate medical records, potentially affecting patient care and treatment decisions.
Check your system ID against the list provided in the recall notice to see if your unit is affected. If it is, you may need to verify and correct the 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-0876-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0876-2020 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.
