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Terminated

NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

FDA Recall Z-1280-2019 · Posted None

Recall StatusTerminated
Product CodeJAK
Date Initiated2018-10-22
Date Terminated2022-08-25
Product Quantity6

Reason for Recall

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.

Firm Action

A customer notification letter will be sent to affected customers by email. All the affected systems will be corrected with the upgraded software in the field free of charge.

Root Cause

Software design

Distribution Pattern

US Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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