18
May
2016

Cl II NeuViz 64 Multi-Slice CT Scanner

,
0

Company: Neusoft Medical Systems Co., Ltd.
Date of Enforcement Report 5/18/2016
Class lI:

PRODUCT

NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Recall Number Z-1650-2016

REASON
It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn’t meet the patient position description, when the scanner position was set to “Right” in the system setting – scanner options.

RECALLING FIRM/MANUFACTURER
Neusoft Medical Systems Co., Ltd. , Shenyang China on 5/2/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7 units

DISTRIBUTION
US Distribution – Including Puerto Rico and the states of IL, CT, SC, NE

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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