Z-2083-2012Class II

NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number...

Name: Z-2083-2012 NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number...
Creator: Philips And Neusoft Medical Systems Co., Ltd.
Published: 2012-06-08
License: https://open.fda.gov/license/

Neusoft Medical Systems Co., Ltd. / initiated 2012-06-08 / Terminated / root cause: design

FDA source

Philips And Neusoft Medical Systems Co., Ltd. began a recall of NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part... on 2012-06-08. FDA classified it as Class II and gives the reason as "One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach". 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-2083-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-08
Posted: 2012-07-26
Terminated: 2012-09-17
Recalling firm: Neusoft Medical Systems Co., Ltd.
Product: NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach.
Root cause tag: design
FDA root cause: Device Design
Action: Philips Healthcare North America Company sent an "Urgent Device Correction NeuViz 16 X-Ray Tube Oil-accumulator Detached" letter and attachments of Annex A Method to Identify Affected Products and Annex B Instruction for Mechanic, dated June 14, 2012, to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to follow the instructions on Annex A and Annex B. Philips and Neusoft Medical Systems planned to release the mandatory Field Change Order (FCO) and FCO kits to all customers by the end of June 2012. If you have any questions about this corrective action program, please contact the Service Support Department, Neusoft Medical Systems, Co., LTD by e-mail to [email protected]
Quantity in commerce: 15 units distributed in the US
Distribution: Nationwide Distribution -- North Carolina, Ohio, and Texas.
Product codes and lots: Serial No.: N16E0 90002, N16E0 90003, N16E0 90004, N16E0 90007, N16E0 90008, N16E0 90010, N16E1 00015, N16E1 00017, N16E1 00023, N16E1 10016, N16E1 10023, N16E1 10026, N16E1 10027, N16E1 10040, and N16E1 10053.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2083-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2083-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-26

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)