GE Healthcare Recalls Innova 2100IQ Angiographic X-ray Systems
GE Healthcare is recalling 13 Innova 2100IQ angiographic X-ray systems due to a potential safety issue that may cause the loss of C-arm gantry motion capability.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 where the loss of motion capability could impact patient safety, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
GE Healthcare is recalling 13 units of the Innova 2100IQ 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 was initiated because GE Healthcare became aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic interventional imaging systems. The affected systems include the Innova, Optima, and Discovery lines.
The recalled units were distributed worldwide, including nationwide in the United States and in various countries such as Argentina, Belgium, Brazil, Canada, Chile, China, France, Germany, Hong Kong, Hungary, India, Indonesia, Italy, Japan, Russia, the United Kingdom, and Vietnam. Healthcare facilities should contact GE Healthcare for further instructions on how to address this issue.
The recalled product
- Product
- GE Healthcare Innova 2100IQ. 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
- Hazard
- Affected units
- 13
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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