GE Healthcare Recalls Innova IGS 540 Angiographic X-ray Systems
GE Healthcare is recalling six Innova IGS 540 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.
Plain-English summary
GE Healthcare is recalling six units of the Innova IGS 540 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. The affected systems include the Innova, Optima, and Discovery lines.
The affected units were distributed worldwide, including in the United States and various international countries. Healthcare facilities should contact GE Healthcare for further instructions regarding the recall and corrective actions.
The recalled product
- Product
- GE Healthcare Innova IGS 540. 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
- 6
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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