CLASS II Device recall · Reported 24 Jun 2015 · FDA Enforcement Report

Neusoft NeuViz 64 Multi-slice CT Scanner System recalled

Neusoft Medical System is recalling Neusoft NeuViz 64 Multi-slice CT Scanner System, distributed in Illinois, Massachusetts, Puerto Rico, South Carolina, Texas. The recall was initiated on 8 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesNeuViz 16/64 Series

Quantity recalled5 installed in US

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1693-2015
FDA event ID: 71306
Recalling firm: Neusoft Medical System, Houston, TX
Classification: Class II
Status: Terminated
Recall initiated: 8 Mar 2014
FDA classified: 16 Jun 2015
Reported: 24 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Imaging Equipment

Timeline

8 Mar 2014	Recall initiated by company
16 Jun 2015	Classified by FDA	+465 days
24 Jun 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing through it. The thinnest part of the compensator is subject to radiation degradation and as a result has been found to fail prematurely. Failure is indicated by pin or ring artifact in the image

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Neusoft NeuViz 64 Multi-slice CT Scanner System

Where it was distributed

Worldwide Distribution - US Distribution including Puerto Rico and to the states of : IL, MA, TX and SC., and to the countries of : China, Malaysia, Lebanon, Ecuador, Egypt, United Arab Emirates,Kazashstan, Tunisia, Angola, Brazil, Uzbekistan, Lebanon, Cote D' ivoire, South Africa, Montenegro and Tajikistan.

Illinois Massachusetts Puerto Rico South Carolina Texas

Questions about this recall

Is Neusoft NeuViz 64 Multi-slice CT Scanner System recalled?

Yes. Neusoft Medical System recalled Neusoft NeuViz 64 Multi-slice CT Scanner System on 8 Mar 2014. The recall is Class II and its status is Terminated. Recall number Z-1693-2015.

Why was it recalled?

Which lots are affected?

NeuViz 16/64 Series

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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