Reported Dec 14, 2016 · Terminated

Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available…

Philips Medical Systems (Cleveland) Inc.

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 Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131

Is this the product you have?

  • Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents.
Lot codes and dates
    • 50001
    • 50002
    • 50004
    • 50005
    • 50006
    • 50008
    • 50009
    • 50100
    • 50101
    • 50102
    • 50103
    • 430000
    • 430001
    • 430002
    • 430003
    • 430004
    • 430006
    • 430007
    • 430501
    • 430502
Amount recalled
20

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

Why it was recalled

A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images

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 Jul 2, 2018 · Data as of Sep 19, 4:46 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.