GE Healthcare Recalls Discovery IGS 730 and 740 X-ray Systems
GE Healthcare is recalling 24 Discovery IGS 730 and 740 angiographic X-ray systems due to a user interface issue that may cause unintentional system motion or rotation.
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 medical device with a potential for unintentional motion or rotation, which poses a risk of harm to patients or operators, but the source text does not report any specific injuries or illnesses.
Plain-English summary
GE Healthcare is recalling 24 units of the Discovery IGS 730 and Discovery IGS 740 angiographic X-ray systems. These systems are indicated for generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular, and nonvascular diagnostic and interventional procedures.
The recall is being issued due to a positioning user interface issue that may result in potential unintentional system motion or rotation. The affected units were distributed worldwide, including in the United States (Colorado, Connecticut, Mississippi, New Jersey, New York, Ohio, and Washington) and in Belgium, Canada, China, France, Germany, Japan, Mexico, Peru, the United Arab Emirates, and the United Kingdom.
Healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue. The source text does not specify a corrective action or a deadline for the recall.
The recalled product
- Product
- GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional…
- Manufacturer
- GE Healthcare
Distribution
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