Reported Dec 12, 2012 · Terminated

NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number…

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 · N/A

Is this the product you have?

  • 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.
Lot codes and dates
  • 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
Amount recalled
20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series

Where it was sold

Why it was recalled

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.

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

Want the full recall guide?

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 8, 2013 · Data as of Sep 19, 5:34 PM UTC

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