Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0773-2019 — NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 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 rec

U.S. FDA — Device Enforcement · China · 2019-01-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0773-2019
Date of alert: 2019-01-09
Country / jurisdiction: China
Risk level: Class II
Risk type: recall
Brand: NEUSOFT MEDICAL SYSTEMS IMP & EX
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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