Reported Mar 20, 2013 · Terminated

GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with…

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 Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2.
Lot codes and dates
  • INNOVA
    • 41001Q
    • 00000000609MC8
    • 00000000605MC6
    • 00000000535MC5
    • 00000000225MC3
    • 00000000226MC1
    • 00000000463MC0
    • 00000000223MC8
    • 00000000377MC2
    • 00000000816MC9
    • 00000000841MC7
    • 00000000469MC7
    • 00000000228MC7
    • 00000000830MC0
    • 00000001258MC3
    • 00000000937MC3
    • 00000000485MC3
    • 00000000376MC4
    • 00000000807MC8
    • 00000001078MC5
    • 00000000821MC9
    • 00000000125MC5
    • 00000000123MC0
    INNOVA
    • 4100
    • 00000000207MC1
    • 00000000823MC5
    • 00000000814MC4
    • 00000000468MC9
    • 00000000484MC6
    • 00000000465MC5
    • 00000000462MC2
    • 00000000229MC5
    • 00000000606MC4
    • 00000000553MC8
    • 00000000669MC2
    • 00000000212MC1
    • 00000000477MC0
    • 00000000667MC6
    INNOVA 31001Q 00000000647MC8 00000000723MC7 00000000620MC5 INNOVA 3100 00000001211MC2 00000000765MC8 INNOVA 21001Q 00000000693MC2 00000000663MC5 00000000661MC9 00000001336MC7 00000001367MC2 INNOVA

    157 of 157 codes

    • 2000
    • 00000000099MC2
    • 00000000109MC9
    • 00000000126MC3
    • 00000000128MC9
    • 00000000140MC4
    • 00000000152MC9
    • 00000000161MC0
    • 00000000164MC4
    • 00000000166MC9
    • 00000000169MC3
    • 00000000171MC9
    • 00000000173MC5
    • 00000000175MC0
    • 00000000176MC8
    • 00000000177MC6
    • 00000000178MC4
    • 00000000179MC2
    • 00000000180MC0
    • 00000000199MC0
    • 00000000201MC4
    • 00000000202MC2
    • 00000000320MC2
    • 00000000323MC6
    • 00000000324MC4
    • 00000000357MC4
    • 00000000358MC2
    • 00000000367MC3
    • 00000000374MC9
    • 00000000375MC6
    • 00000000410MC1
    • 00000000423MC4
    • 00000000429MC1
    • 00000000499MC4
    • 00000000501MC7
    • 00000000502MC5
    • 00000000504MC1
    • 00000000513MC2
    • 00000000517MC3
    • 00000000163MC6
    • 00000000124MC8
    • 00000000151MC1
    • 00000000153MC7
    • 00000000154MC5
    • 00000000165MC1
    • 00000000366MC5
    • 00000000430MC9
    • 00000000431MC7
    • 00000000459MC8
    • 00000000500MC9
    • 00000000514MC0
    • 00000000127MC1
    • 00000000460MC6
    • 00000000097MC6
    • 00000000426MC7
    • 00000000108MC1
    • 00000000447MC3
    • 00000000168MC5
    • 00000000085MC1
    • 00000000098MC4
    ADVANTX

    95 of 95 codes

    • 00000000290MC7
    • 00000000726MC0
    • 00000000546MC2
    • 00000128246M06
    • 00000000697MC3
    • 00000000378MC0
    • 00000000183MC4
    • 00000000209MC7
    • 00000000119MC8
    • 00000000554MC6
    • 00000000586MC8
    • 00000000117MC2
    • 00000000555MC3
    • 00000000698MC1
    • 00000000120MC6
    • 00000000118MC0
    • 00000000116MC4
    • 00000000291MC5
    • 00000000703MC9
    • 00000000608MC0
    • 00000000750MC0
    • 00000000658MC5
    • 00000000939MC9
    • 00000000987MC8
    • 00000000940MC7
    • 00000001062MC9
    • 00000000705MC4
    • 00000000902MC7
    • 00000000812MC8
    • 00000000903MC5
    • 00000000832MC6
    • 00000000990MC2
    • 00000000873MC0
    • 00000000649MC4
    • 00000001382MC1
    • 00000000876MC3
    • 00000000842MC5
    • 00000000874MC8
    • 00000000843MC3
    • 00000000989MC4
    • 00000001080MC1
    • 00000000859MC9
    • 00000000819MC3
    • 00000000711MC2
    • 00000000679MC1
    • 00000000135MC4
    • 00000000677MC5
    • 00000000696MC5
    • 00000000219MC6
    • 00000000145MC3
    • 00000128106M02
    • 00000000136MC2
    • 00000000637MC9
    • 0000000128124M
    • 00000000592MC6
    • 00000000638MC7
    • 00000000635MC3
    • 00000000509MC0
    • 00000000150MC3
    • 00000000130MC5
Amount recalled
297

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

Why it was recalled

A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 16, 2014 · Data as of Sep 19, 7:47 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.