GE Healthcare, LLC: Medical Device Recall in 2012 - (Recall #: Z-0114-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

GE Healthcare innova 3100-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.

Product Classification:

Class II

Date Initiated: December 20, 2011

Date Posted: October 31, 2012

Recall Number: Z-0114-2013

Event ID: 63027

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.

Status: Terminated

Product Quantity: 199 installed in the US

Code Information:

Model number - 5892935G052G

Distribution Pattern:

Nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated