Z-0466-2013Class II

NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System...

Name: Z-0466-2013 NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System...
Creator: Philips And Neusoft Medical Systems Co., Ltd.
Published: 2012-10-18
License: https://open.fda.gov/license/

Neusoft Medical Systems Co., Ltd. / initiated 2012-10-18 / Terminated / root cause: design

FDA source

Philips And Neusoft Medical Systems Co., Ltd. began a recall of NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner... on 2012-10-18. FDA classified it as Class II and gives the reason as "The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0466-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-18
Posted: 2012-12-04
Terminated: 2013-07-08
Recalling firm: Neusoft Medical Systems Co., Ltd.
Product: NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as 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 four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners.
Root cause tag: design
FDA root cause: Device Design
Action: Philips and Neusoft Medical Systems Co., Ltd. sent an Urgent Device Correction NeuViz Dual, NeuViz 16 letter, dated Oct. 18, 2012, to all affected US customers and distributors. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to: 1. Have a mechanic check the patient table top screws fixing. Detailed instructions are attached as Annex with the letter. 2. If it is found that table top screws are improperly assembled, stop using the product and contact local Service personnel for repair. Philips and Neusoft Medical Systems Co., Ltd is in the process of upgrading devices with aforementioned kits and will contact customers to arrange for an update to affected systems. If you have any questions about this corrective action program, please contact the Service Support Department, Neusoft Medical Systems Co. Ltd. at [email protected] For questions regarding this recall call 425-487-7665.
Quantity in commerce: 20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series
Distribution: Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico.
Product codes and lots: NeuViz 16 system Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120022, N16E120020, N16E120023, N16E120024. Neuviz Dual Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0466-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0466-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-04

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)