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FDA Device 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-…

On 2016-05-04 the FDA classified a Class II recall of NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-… by Philips And Neusoft Medical Systems, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1573-2016
ClassificationClass II
Statusterminated
Initiated2016-03-24
Published2016-05-04
Last updated2026-09-13 11:54 UTC
CompanyPhilips And Neusoft Medical Systems
DistributionCT, FL, LA, MO, NC, NE, OH, PR, SC, TX

Product

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.

Reason

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

Identifiers

code_info
Serial Numbers: N16E090002, N16E090003, N16E090007, N16E090008, N16E090010, N16E100023, N16E110023, N16E110026, N16E120…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1573-2016%22

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