PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: October 31, 2012 Initiated: December 20, 2011 #Z-0113-2013

Product Description

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.

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.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
199 installed in the US
Distribution
Nationwide distribution
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by GE Healthcare, LLC. Units affected: 199 installed in the US.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 31, 2012. Severity: Moderate. Recall number: Z-0113-2013.

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