NeuViz 128 Multi-slice CT Scanner with software version 1.0.8.5010O+P04 may produce incorrect scan images if used for scans longer than 500mm. Affected units have series numbers N1281180242E, N1281170231E, N1281180248E.
For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV the actual start and end position may not be consistent with the planned positons.
NeuViz 128 Multi-slice CT scanners with software version 1.0.8.5010O+P04 may create incorrect scan images for scans longer than 500mm. This could lead to misaligned scan positions during subsequent clinical scans, potentially affecting diagnosis.
When scanning lengths exceed 500mm, aborting or skipping reconstructed scans can cause the image field of view to be incorrect. Subsequent scans using this wrong field of view may not align with planned positions, potentially leading to misdiagnosis.
Healthcare facilities using NeuViz 128 CT scanners with the specified software version. Patients undergoing scans with these systems may be at risk of misdiagnosis if the scan parameters are incorrect.
Check for series numbers N1281180242E, N1281170231E, or N1281180248E on the scanner. The software version is 1.0.8.5010O+P04 or 1.0.8.521 9+PO1.
Verify the software version on your scanner; affected units have version 1.0.8.5010O+P04 or 1.0.8.521 9+PO1.
The affected software versions are 1.0.8.5010O+P04 and 1.0.8.521 9+PO1.
Check the series numbers on your scanner; affected units have series numbers N1281180242E, N1281170231E, or N1281180248E.
The recall does not specify a remedy, so no action is required unless you experience incorrect scan images.
We’ve drafted a message you can send Neusoft to request your refund or repair — edit it as you like.
Subject: Recall Z-0773-2019 — Neusoft Neusoft Hello, I own a Neusoft that is covered by recall Z-0773-2019 from Neusoft. 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.
