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

Recall Z-1573-2016 — NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.

U.S. FDA — Device Enforcement · China · 2016-03-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1573-2016
Date of alert
2016-03-24
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: The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patient's images before pasting, a previous patient's image may be present in the clipboard and be
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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