Philips And Neusoft Medical Systems Co., Ltd.: Medical Device Recall in 2013 - (Recall #: Z-1165-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 4, 2013

Date Posted: May 1, 2013

Recall Number: Z-1165-2013

Event ID: 64783

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.

Status: Terminated

Product Quantity: 23 units

Code Information:

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.

Distribution Pattern:

Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated