Neusoft recalls NeuViz 128 Multi-slice CT scanners due to a software defect that can cause image loss during helical scans with ClearView function. Affected units have specific series numbers.
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 128 Multi-slice CT scanners because a software issue can cause image loss during certain scans. This affects medical imaging accuracy and could lead to misdiagnosis if not corrected.
A software defect causes electromagnetic interference during small arc helical scans with ClearView function. This can lead to incorrect flying focal spot sequences, resulting in image loss during reconstruction. The issue does not cause immediate harm but affects scan accuracy.
Healthcare facilities using the NeuViz 128 CT scanners with specific series numbers are affected. Medical staff and patients using these scanners may experience image loss during helical scans with ClearView function.
Check if your scanner has series numbers N1281160084E, N1281160085E, N1281170161E, N1281170231E, N1281180242E, or N1281180248E. The product is a whole-body CT scanner system used for medical imaging.
Identify if your scanner has the series numbers listed: N1281160084E, N1281160085E, N1281170161E, N1281170231E, N1281180242E, or N1281180248E.
The defect causes electromagnetic interference during small arc helical scans with ClearView function, leading to incorrect flying focal spot sequences and image loss.
Check if your scanner has the series numbers: N1281160084E, N1281160085E, N1281170161E, N1281170231E, N1281180242E, or N1281180248E.
No, the recall does not require immediate discontinuation. Affected units may continue use but with the risk of image loss during specific scans.
We’ve drafted a message you can send Neusoft to request your refund or repair — edit it as you like.
Subject: Recall Z-1280-2019 — Neusoft Neusoft Hello, I own a Neusoft that is covered by recall Z-1280-2019 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.