Neusoft recalls NeuViz 16 Essence CT scanners due to a software defect that can cause image loss during helical scans with ClearView function. Affected units have series numbers N16E180037E and N16E180047E.
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 16 Essence 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.
The software defect causes electromagnetic interference during helical scans with ClearView function. This can lead to incorrect flying focal spot sequences, resulting in image loss during reconstruction. The issue occurs when small arcs of uninterrupted scanning happen during the scan process.
Healthcare facilities using the NeuViz 16 Essence CT scanners with series numbers N16E180037E or N16E180047E are most at risk. Patients receiving scans on these units may experience inaccurate imaging results.
Check if your scanner has series numbers N16E180037E or N16E180047E. The NeuViz 16 Essence Multi-slice CT Scanner System is used for whole-body CT imaging.
Look for the series numbers N16E180037E or N16E180047E on your scanner.
The defect causes electromagnetic interference during helical scans with ClearView function, leading to incorrect flying focal spot sequences and image loss.
The issue can cause image loss during reconstruction, potentially leading to misdiagnosis if the affected scans are used for patient care.
No, the recall does not require stopping use. The remedy is not specified in the record.
We’ve drafted a message you can send Neusoft to request your refund or repair — edit it as you like.
Subject: Recall Z-1281-2019 — Neusoft Neusoft Hello, I own a Neusoft that is covered by recall Z-1281-2019 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.
