Z-1573-2016Class II

NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system...

Name: Z-1573-2016 NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system...
Creator: Philips and Neusoft Medical Systems Co., Ltd.
Published: 2016-03-24
License: https://open.fda.gov/license/

Neusoft Medical Systems Co., Ltd. / initiated 2016-03-24 / Terminated / root cause: software

FDA source

Philips and Neusoft Medical Systems Co., Ltd. began a recall of 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... on 2016-03-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1573-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-24
Posted: 2016-04-27
Terminated: 2016-11-23
Recalling firm: Neusoft Medical Systems Co., Ltd.
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.
Product code: JAK System, X-Ray, Tomography, Computed
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
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Affected consignees will be notified of the recall via letter on March 24, 2016. Mandatory Field Change Order and FCO kits will be released to all affected systems in June, 2016.
Quantity in commerce: 37 units
Distribution: NC, OH, NE, SC, TX, LA, PR, MO, FL, CT
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1573-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1573-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-27

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)