Reported Feb 5, 2014 · Terminated
GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage
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 Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices. |
| 2 | Communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface. |
| 3 | Interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems. |
- Lot codes and dates
- Serial # System ID
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
- Serial # System ID
- Amount recalled
- 28 (12 US, 16 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
GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems. While performing fluoroscopy on a biplane fluoroscopy unit, there is a potential for loss of the x-ray imaging function when the user changes the size of the lateral FOV (Field of View) and releases the biplane footswitch pedal simultaneously. This could lead to a system lock up requiring
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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