Reported Aug 8, 2018 · Terminated

Optima CT 520

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?

  • Optima CT 520
Lot codes and dates
  • Serial number, CBCRG1700051HM, System ID Number 580622O520, UDI Number 01008406821025681117120021CBCRG1700051HM
Amount recalled
42 units total

This recall covers 10 products

The agency filed one notice per product. You are reading one of them; the other 9 are below.

Where it was sold

Why it was recalled

Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

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 Feb 8, 2019 · Data as of Sep 19, 4:47 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.