Reported Mar 6, 2013 · Terminated

GE Healthcare Definium 5000 / 5220493 X-Ray System

GE Healthcare, LLC

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: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

  • GE Healthcare Definium 5000 / 5220493 X-Ray System
Lot codes and dates
  • Definium Model 5000/5220493
Amount recalled
312 installed in US

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.

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 Dec 5, 2013 · Data as of Sep 19, 4:49 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.