Z-0846-2011

The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as...

Name: Z-0846-2011 The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as...
Creator: Philips And Neusoft Medical Systems Co., Ltd.
Published: 2010-02-10
License: https://open.fda.gov/license/

Neusoft Medical Systems Co., Ltd. / initiated 2010-02-10 / Terminated

FDA source

Philips And Neusoft Medical Systems Co., Ltd. began a recall of The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. Labeling on the device... on 2010-02-10. The reason FDA records is "Potential for the CT patient table top to become detached from the carrier due to missing washers". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0846-2011
Status: Terminated
Initiated: 2010-02-10
Posted: 2011-01-04
Terminated: 2011-04-15
Recalling firm: Neusoft Medical Systems Co., Ltd.
Product: The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. Labeling on the device reads in part: "***Neusoft NeuViz Dual MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. ADDRESS: NEUSOFT PARK, HUN NAN INDUSTRIAL AREA, SHENYANG 110179, CHINA***". Device is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Potential for the CT patient table top to become detached from the carrier due to missing washers.
FDA root cause: Other
Action: Neusoft Medical Systems Co., China sent an URGENT DEVICE CORRECTION letter dated Feb. 10, 2010 to their distributor in NC. On 02/12/10, The distributor sent the same letter to their consignees. The firm informed this distributor that there was report of the four screws that secure the patient table top to the carrier that did not have the proper washers in place which caused the table top to detach. If the issue would reoccur, there is a potential for the table top to fall and cause patient injury. Customers were instructed to check the patient table top fixing. If it is found that the the assembly is improper customers were instructed to top using the product and contact local Service personnel for repair. Any customer can contact Service Support Department, Neusoft Medical Systems Co, LTD at [email protected] or Service Support Department at [email protected] for questions about this recall.
Quantity in commerce: 26 devices
Distribution: Nationwide Distribution including NC
Product codes and lots: Part number: NeuViz Dual 989605651321. SERIAL NUMBERS: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR080031, NDHR090003, and NDHR090012.

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)