Reported Dec 14, 2016 · Terminated

IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by…

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?

  • IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Lot codes and dates
    • 860008
    • 860009
    • 860010
    • 860011
    • 860012
    • 860013
    • 860014
    • 860015
    • 860016
    • 860017
    • 860018
    • 860019
    • 860020
    • 860021
    • 860022
    • 860023
    • 860024
    • 860028
    • 860026
    • 860029
    • 860030
    • 860031
    • 860034
    • 860035
Amount recalled
24

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, 5:20 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.