Z-2307-2008

NeuViz Dual series computed Tomography Scanner System, X-Ray System

Name: Z-2307-2008 NeuViz Dual series computed Tomography Scanner System, X-Ray System
Creator: Philips And Neusoft Medical Systems Co., Ltd.
Published: 2008-06-23
License: https://open.fda.gov/license/

Neusoft Medical Systems Co., Ltd. / initiated 2008-06-23 / Terminated / root cause: manufacturing process

FDA source

Philips And Neusoft Medical Systems Co., Ltd. began a recall of NeuViz Dual series computed Tomography Scanner System, X-Ray System on 2008-06-23. The reason FDA records is "Potential for R-host box and components inside to be detached of its mounting during the gantry rotor rotation. There is a potential for components to be damaged inside the system gantry and for the internal components...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2307-2008
Status: Terminated
Initiated: 2008-06-23
Posted: 2008-09-17
Terminated: 2010-09-24
Recalling firm: Neusoft Medical Systems Co., Ltd.
Product: NeuViz Dual series computed Tomography Scanner System, X-Ray System
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Potential for R-host box and components inside to be detached of its mounting during the gantry rotor rotation. There is a potential for components to be damaged inside the system gantry and for the internal components to be expelled from the system gantry and injure the patient, operator, bystander or service people.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 6/23/08/08, the Philips Neusoft sent a letter dated 6/10/08 to their US customers explaining the problem, under what circumstances it can occur, and the actions that should be taken by the customer/user in order to prevent risks for patients or users. The field correction is install a R-host bracket to aid supporting of the R-host computer. The letter included additional information to customers who had already received the field action (this was an on-going activity that was re-classified as a potential safety). Customers did not receive the additional information about the status of their upgrade if the upgrade had not occurred at the time of the mailing. They were informed that they would be contacted by Newsoft Medical systems representative for the planning of this repair. If you have questions contact Service Support Department at [email protected].
Quantity in commerce: 15 units in US
Distribution: The units were distributed to one distributor in NC, and further distributed to medical facilities located in CO, FL, KY, NC, SC, TN and TX.
Product codes and lots: Serial numbers 400562, 400563, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, and NDH034EI

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)