Z-1165-2013Class II

NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed...

Name: Z-1165-2013 NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed...
Creator: Philips And Neusoft Medical Systems Co., Ltd.
Published: 2013-03-04
License: https://open.fda.gov/license/

Neusoft Medical Systems Co., Ltd. / initiated 2013-03-04 / Terminated

FDA source

Philips And Neusoft Medical Systems Co., Ltd. began a recall of NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 CT... on 2013-03-04. FDA classified it as Class II and gives the reason as "User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1165-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-04
Posted: 2013-04-23
Terminated: 2013-11-22
Recalling firm: Neusoft Medical Systems Co., Ltd.
Product: NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. 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. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.
FDA root cause: Use error
Action: The firm, Neusoft Medical Systems Co., Ltd., sent an "URGENT DEVICE CORRECTION" NeuViz Dual and NeuViz 16 letter, dated Mar. 4, 2013, to their US consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review this information with all members of their staff and retain a copy of the letter with the equipment Instruction For Use. Customers with questions should contact the Service Support Department by email to [email protected]
Quantity in commerce: 23 units
Distribution: Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.
Product codes and lots: Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120020, N16E120022, N16E120023, N16E120024, N16E120052, N16E120053, and N16E130002.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1165-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1165-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-23
Z-1166-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-23

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)