Reported Jul 8, 2015 · Terminated

GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human…

GE Healthcare

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 · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

  • GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Lot codes and dates
  • Serial Number System ID
    • 0000010C2M037O
    • 620272INNOVA31
    • 0000009C2M0192
    • X98766705
    • 00000464106BU4
    • A5127281
    • 00000007C20175
    • RU2741VA01
    • 0000013C2S0087
    • 082416100052
    • 0000010C2M0299
    • 082416100030
Amount recalled
6

This recall covers 14 products

The agency filed one notice per product. You are reading one of them; the other 13 are below.

1 more are in the archive.

Where it was sold

Why it was recalled

GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).

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 Oct 28, 2015 · Data as of Sep 19, 6:01 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.