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

Recall Z-2083-2012 — NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "NeusoftNeuViz16 MULTI-SLICE CT SCANNER SYSTEMMANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTDMANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL

U.S. FDA — Device Enforcement · China · 2012-06-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2083-2012
Date of alert: 2012-06-08
Country / jurisdiction: China
Risk level: Class II
Risk type: recall
Brand: Philips And Neusoft Medical Systems Co., Ltd.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 989605858501

Reported risk: One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach.

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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