GE Healthcare Recalls Discovery IGS 730 Systems Due to Gantry Motion Loss
GE Healthcare is recalling four Discovery IGS 730 angiographic X-ray systems worldwide due to a potential safety issue that may result in 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 (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare is recalling four units of the Discovery IGS 730 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 conducted because the company recently 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 units are 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. Specific serial numbers and system IDs for the four affected units are listed in the official recall documentation.
Healthcare facilities and consumers should contact GE Healthcare for further instructions regarding the recall and potential corrective actions. The source text does not report any specific injuries or illnesses associated with this issue.
The recalled product
- Product
- GE Healthcare Discovery IGS 730. 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
- 4
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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