CLASS II Device recall · Reported 4 Jan 2017 · FDA Enforcement Report

NeuViz 128 Multi-slice CT Scanner System recalled

Neusoft Medical Systems Co is recalling NeuViz 128 Multi-slice CT Scanner System. The recall was initiated on 31 Aug 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesNeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version

Quantity recalled23 units

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-0876-2017
FDA event ID: 75383
Recalling firm: Neusoft Medical Systems Co, Shenyang, N/A
Classification: Class II
Status: Terminated
Recall initiated: 31 Aug 2016
FDA classified: 23 Dec 2016
Reported: 4 Jan 2017
Type: FDA Mandated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

31 Aug 2016	Recall initiated by company
23 Dec 2016	Classified by FDA	+114 days
4 Jan 2017	Published in enforcement report	+12 days

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

Reason for recall

The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version

Where it was distributed

US Distribution

Questions about this recall

Is NeuViz 128 Multi-slice CT Scanner System recalled?

Yes. Neusoft Medical Systems Co recalled NeuViz 128 Multi-slice CT Scanner System on 31 Aug 2016. The recall is Class II and its status is Terminated. Recall number Z-0876-2017.

Why was it recalled?

Which lots are affected?

NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version

Where was it sold?

US Distribution

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.

More recalls from Neusoft Medical Systems Co

All 8

Reported	Class	Recall	Company	Reason	Where
29 May 2019Device	CLASS II	NeuViz 128 Multi-slice CT Scanner System recalled	Neusoft Medical Systems Co	Device Malfunction	Nationwide
29 May 2019Device	CLASS II	NeuViz 16 Essence Multi-slice CT Scanner System recalled	Neusoft Medical Systems Co	Device Malfunction	Nationwide
29 May 2019Device	CLASS II	NeuViz 64 Multi-slice CT Scanner System recalled	Neusoft Medical Systems Co	Device Malfunction	Nationwide
6 Sep 2017Device	CLASS II	Neusoft NeuViz 128 Multi-slice CT Scanner System recalled	Neusoft Medical Systems Co	Device Malfunction	Nationwide
6 Sep 2017Device	CLASS II	Neusoft Medical NeuViz 64 Multi-slice CT Scanner System recalled	Neusoft Medical Systems Co	Device Malfunction	Nationwide

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