GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use in...
FDA Recall #Z-0115-2013 — Class II — December 20, 2011
Product Description
GE Healthcare innova 3131-IQ 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.
Reason for Recall
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.
Recalling Firm
GE Healthcare, LLC — Waukesha, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
199 installed in the US
Distribution
Nationwide distribution
Code Information
Model number - 5892935G052G
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated