GE Healthcare Recalls Innova IGS 540 Imaging Systems Due to Motion Loss
GE Healthcare is recalling 10 Innova IGS 540 systems because they may lose real-time imaging or gantry motion due to electromagnetic sensitivity.
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 risk-of-harm product (medical device) where the defect could impede critical imaging during procedures, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for unreported harm.
Plain-English summary
GE Healthcare, LLC is recalling 10 units of the Innova IGS 540, a medical device indicated for generating fluoroscopic and rotational images of human anatomy for various diagnostic and interventional procedures. The recall affects devices distributed in the United States (California, Colorado, Florida, Missouri, Pennsylvania) and internationally in Belgium, China, Colombia, France, Greece, Mexico, and Russia.
The recall is due to a defect in the Electromagnetic (EM) sensitivity of the grid detection mechanism. This issue may cause the affected devices to experience a loss of real-time interventional imaging and/or gantry motion. The source text does not report any specific injuries, illnesses, or fatalities associated with this defect.
Healthcare facilities and users of the affected devices should contact GE Healthcare for further instructions on how to address the issue. The recall covers specific serial numbers and system IDs listed in the official agency documentation.
The recalled product
- Product
- Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
- 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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