GE Healthcare Recalls Innova IGS 630 Angiographic X-ray Systems
GE Healthcare is recalling eight Innova IGS 630 angiographic X-ray systems due to a potential safety issue that may cause 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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare is recalling eight units of the Innova IGS 630 angiographic X-ray system. These devices 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. This issue affects Innova, Optima, and Discovery systems.
The affected units were distributed worldwide, including in the United States and various international locations. Specific serial numbers and system IDs for the eight affected units are listed in the official recall documentation. Users of these devices should contact GE Healthcare for further instructions on how to address the potential safety issue.
The recalled product
- Product
- GE Healthcare Innova IGS 630. 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
- 8
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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