Reported Jul 10, 2013 · Terminated
GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in…
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 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures.
- Lot codes and dates
- SERIAL NUMBER
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
- SERIAL NUMBER
- Amount recalled
- 48
Where it was sold
Why it was recalled
GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems.
This product could cause temporary or reversible health problems — stop using it.
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