FDAFDA · Food and drugs·Recall number Z-0113-2013
GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
Published October 31, 2012 · Recall initiated: December 20, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Nationwide distribution
- Lot
- Model number 5892935G052G
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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