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

Recall Z-3044-2017 — Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Scanner System can be u

U.S. FDA — Device Enforcement · China · 2017-05-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3044-2017
Date of alert: 2017-05-19
Country / jurisdiction: China
Risk level: Class II
Risk type: recall
Brand: Neusoft Medical Systems Co., Ltd.
Product category: device
Product type: Devices

Reported risk: Software defect

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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