CLASS II Device recall · Reported 4 May 2016 · FDA Enforcement Report

NeuViz 16 Multi-Slice CT Scanner System PN recalled

Philips and Neusoft Medical Systems Co is recalling NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography, distributed in 10 states. The recall was initiated on 24 Mar 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: N16E090002, N16E090003, N16E090007, N16E090008, N16E090010, N16E100023, N16E110023, N16E110026, N16E120016, N16E120023, N16E120052, N16E120053, N16E130012, N16E130038, N16E130045, N16E140008, N16E140007, N16E140012, N16E140017, N16E140020, N16E140029, N16E140056, N16E140057, N16E140058, N16E150004, N16E150014, N16E150013, N16E150015, N16E150025, N16E150024, N16E150027, N16E150038, N16E150039, N16E150040, N16E100017, N16E140030 and N16E140031

Quantity recalled37 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-1573-2016
FDA event ID: 73741
Recalling firm: Philips and Neusoft Medical Systems Co, Shenyang, N/A
Classification: Class II
Status: Terminated
Recall initiated: 24 Mar 2016
FDA classified: 27 Apr 2016
Reported: 4 May 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

24 Mar 2016	Recall initiated by company
27 Apr 2016	Classified by FDA	+34 days
4 May 2016	Published in enforcement report	+7 days

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

Reason for recall

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

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 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.

Where it was distributed

NC, OH, NE, SC, TX, LA, PR, MO, FL, CT

Connecticut Florida Louisiana Missouri North Carolina Nebraska Ohio Puerto Rico South Carolina Texas

Questions about this recall

Is NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography recalled?

Yes. Philips and Neusoft Medical Systems Co recalled NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography on 24 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1573-2016.

Why was it recalled?

Which lots are affected?

Serial Numbers: N16E090002, N16E090003, N16E090007, N16E090008, N16E090010, N16E100023, N16E110023, N16E110026, N16E120016, N16E120023, N16E120052, N16E120053, N16E130012, N16E130038, N16E130045, N16E140008, N16E140007, N16E140012, N16E140017, N16E140020, N16E140029, N16E140056, N16E140057, N16E140058, N16E150004, N16E150014, N16E150013, N16E150015, N16E150025, N16E150024, N16E150027, N16E150038, N16E150039, N16E150040, N16E100017, N16E140030 and N16E140031

Where was it sold?

NC, OH, NE, SC, TX, LA, PR, MO, FL, CT

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 Philips and Neusoft Medical Systems Co

All 5

Reported	Class	Recall	Company	Reason	Where
1 May 2013Device	CLASS II	NeuViz Dual series CT Scanner System recalled	Philips And Neusoft Medical Systems Co	Other	Nationwide
1 May 2013Device	CLASS II	NeuViz 16 Multi-Slice CT Scanner System recalled	Philips And Neusoft Medical Systems Co	Other	Nationwide
12 Dec 2012Device	CLASS II	NeuViz 16 Multi-Sliced CT Scanner System recalled	Philips And Neusoft Medical Systems Co	Other	Nationwide
1 Aug 2012Device	CLASS II	NeuViz 16 Multi-Slice CT Scanner System is a computed recalled	Philips And Neusoft Medical Systems Co	Other	Nationwide

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