Reported Jul 8, 2015 · Terminated
GE Healthcare Innova IGS 530. 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 IGS 530. 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 Not Available
702731CATH30000013C2R00036012883100CV415C2R0084702880CATH215C2R0086GON430016515C2R008591878753015C2R0087814877EP0000015C2R0091GON14411410000014C2R0188XV650620BU80000015C2R0083GON14872690000015C2R0088GON42710860000015C2R0064080041RX1815C2R0055414649IGS215C2R0072GON42119040000015C2R007400040773510000015C2R00660824161900290000015C2R00700824161000920000015C2R0071082416190026
- Serial Number System ID Not Available
- Amount recalled
- 17
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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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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