GE Healthcare Recalls Angiographic X-ray Systems Due to Motion Loss
GE Healthcare is recalling three Discovery and Innova IGS 740 angiographic X-ray systems because they may lose 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 'High' severity criteria.
Plain-English summary
GE Healthcare is recalling three units of the Discovery IGS 740 and Innova IGS 740 angiographic X-ray systems. These systems are used to generate fluoroscopic and rotational images of human anatomy for diagnostic, interventional, and image-guided surgical procedures.
The recall is due to a potential safety issue that may result in the loss of C-arm gantry motion capability on these fluoroscopic interventional imaging systems. The affected units are distributed worldwide, including in the United States and various international locations.
The source text does not specify specific actions for consumers or patients, as these are professional medical devices. Healthcare facilities should contact GE Healthcare for further instructions regarding the affected serial numbers.
The recalled product
- Product
- GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. 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
- 3
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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