GE Healthcare Recalls Innova 4100IQ Fluoroscopic Imaging Systems
GE Healthcare is recalling six Innova 4100IQ fluoroscopic systems due to a defect that may cause loss of real-time imaging or gantry motion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a functional failure (loss of imaging/motion) poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
GE Healthcare, LLC is recalling six units of the Innova 4100IQ fluoroscopic imaging system. These devices are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures.
The recall is being conducted because the devices may experience a loss of real-time interventional imaging and/or gantry motion. This issue is attributed to the electromagnetic (EM) sensitivity of the grid detection mechanism.
The affected units were distributed worldwide, including in the United States (California, Colorado, Florida, Missouri, and Pennsylvania) and in Belgium, China, Colombia, France, Greece, Mexico, and Russia. Users of these devices should contact GE Healthcare for further instructions on how to address the defect.
The recalled product
- Product
- Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
- Manufacturer
- GE Healthcare, LLC
Distribution
Part of a larger recall action
This product is one of 3 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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