Reported Aug 1, 2012 · Terminated

NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The…

Philips And Neusoft Medical Systems Co., Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips And Neusoft Medical Systems Co., Ltd. · 16 Century Road, Neusoft Park, · Shenyang, Liaoning · N/A

Is this the product you have?

  • 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***"
Lot codes and dates
    • 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
Amount recalled
15 units distributed in the US

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 17, 2012 · Data as of Sep 19, 5:24 PM UTC

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