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Recall Observatory FDA recall evidence

Device product

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***".

Z-2083-2012

June 08, 2012

Class II

Product summary

Firm
Philips And Neusoft Medical Systems Co., Ltd.
Event
Event 62481
Status
Terminated
Classification
Class II
Quantity
15 units distributed in the US
Official record key
device-enforcement:Z-2083-2012

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.