GE Healthcare Recalls Innova IGS 520 Angiographic X-ray Systems
GE Healthcare is recalling 10 Innova IGS 520 angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.
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 medical device with a potential safety issue that could lead to loss of motion capability during procedures, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
GE Healthcare is recalling 10 units of the Innova IGS 520 angiographic X-ray system. These systems are used to generate fluoroscopic and rotational images of human anatomy for diagnostic, interventional, and image-guided surgical procedures.
The recall is being issued because GE Healthcare has become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic interventional imaging systems. This issue affects Innova, Optima, and Discovery systems.
The affected units were distributed worldwide, including in the United States (nationwide) and in countries such as Argentina, Belgium, Brazil, Canada, Chile, China, France, Germany, Hong Kong, Hungary, India, Indonesia, Italy, Japan, Russia, the United Kingdom, and Vietnam. Specific serial numbers and system IDs for the affected units are listed in the official recall documentation.
The recalled product
- Product
- GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
- Manufacturer
- GE Healthcare
- Affected units
- 10
Distribution
Part of a larger recall action
This product is one of 13 recalled by GE Healthcare 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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