Philips And Neusoft Medical Systems Co., Ltd.: Medical Device Recall in 2012 - (Recall #: Z-0466-2013)

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-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 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.

Product Classification:

Class II

Date Initiated: October 18, 2012

Date Posted: December 12, 2012

Recall Number: Z-0466-2013

Event ID: 63553

Reason for Recall:

The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners.

Status: Terminated

Product Quantity: 20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series

Code Information:

NeuViz 16 system Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120022, N16E120020, N16E120023, N16E120024. Neuviz Dual Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013.

Distribution Pattern:

Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated