Z-2235-2008

NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray...

Name: Z-2235-2008 NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray...
Creator: Philips And Neusoft Medical Systems Co., Ltd.
Published: 2007-12-17
License: https://open.fda.gov/license/

Neusoft Medical Systems Co., Ltd. / initiated 2007-12-17 / Terminated / root cause: software

FDA source

Philips And Neusoft Medical Systems Co., Ltd. began a recall of NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray computed tomography scanner which features a... on 2007-12-17. The reason FDA records is "Labeling of patient position on scanned image does not match actual patient orientation". 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-2235-2008
Status: Terminated
Initiated: 2007-12-17
Posted: 2008-09-17
Terminated: 2012-02-16
Recalling firm: Neusoft Medical Systems Co., Ltd.
Product: NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Labeling of patient position on scanned image does not match actual patient orientation.
Root cause tag: software
FDA root cause: Software design
Action: On 12/17/08 the distributor sent a letter dated 12/13/07 to their customers explaining the problem and under what circumstances it can occur, the actions that should be taken by the customer/user in order to prevent risks for patients or users, and that the customer/user will be contacted for scheduling of a software upgrade by the distributor. Contact NEUISYS Service Support Department at 1-877-299-9052 for assistance.
Quantity in commerce: 15 units
Distribution: Distribution in US: 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)