Reported Dec 24, 2014 · Terminated
Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic…
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?
- Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
- Lot codes and dates
- Mfg Lot or Serial # System ID
00000583668BU9610983INNOVA300000643314BU808240609002400000644609BU008240621001100000645290BU808240611000600000645780BU808240604003200000648200BU4082406070014
- Mfg Lot or Serial # System ID
- Amount recalled
- 6 (1 US, 5 OUS)
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
Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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