Philips And Neusoft Medical Systems Co., Ltd.: Medical Device Recall in 2012 - (Recall #: Z-2083-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".

Product Classification:

Class II

Date Initiated: June 8, 2012

Date Posted: August 1, 2012

Recall Number: Z-2083-2012

Event ID: 62481

Reason for Recall:

One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach.

Status: Terminated

Product Quantity: 15 units distributed in the US

Code Information:

Serial No.: N16E0 90002, N16E0 90003, N16E0 90004, N16E0 90007, N16E0 90008, N16E0 90010, N16E1 00015, N16E1 00017, N16E1 00023, N16E1 10016, N16E1 10023, N16E1 10026, N16E1 10027, N16E1 10040, and N16E1 10053.

Distribution Pattern:

Nationwide Distribution -- North Carolina, Ohio, and Texas.

Voluntary or Mandated:

Voluntary: Firm initiated