Neusoft recalls NeuViz 64 Multi-slice CT scanners with a software defect that can cause image loss during helical scans using ClearView function. Affected models include N64E120022E through N641N180205E.
Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.
Neusoft is recalling its NeuViz 64 Multi-slice CT scanners due to a software defect that may cause image loss during certain scans. This affects the accuracy of medical imaging and could lead to incorrect diagnoses if the issue isn't fixed.
A software defect during helical scans with ClearView function can cause electromagnetic interference that disrupts the flying focal spot sequence. This leads to incorrect image reconstruction and potential image loss in scans, which may affect diagnostic accuracy.
Healthcare facilities using the NeuViz 64 CT scanners with specific model numbers listed in the recall. Medical staff and patients using these scanners are at risk of inaccurate imaging results.
Check if your scanner has model numbers starting with N64E120022E through N641N180205E. The product is a whole-body CT scanner used for medical imaging.
Reach out to Neusoft Medical Systems Co., Ltd. to confirm if your scanner is affected and get guidance on next steps.
Models N64E120022E through N641N180205E (as listed in the recall).
A software defect during helical scans with ClearView function can cause electromagnetic interference that leads to incorrect image reconstruction and image loss.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Neusoft to request your refund or repair — edit it as you like.
Subject: Recall Z-1279-2019 — Neusoft Neusoft Hello, I own a Neusoft that is covered by recall Z-1279-2019 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.