GE Healthcare Recalls Discovery IGS 730 X-Ray Systems for Boot Failure
GE Healthcare is recalling four Discovery IGS 730 Cardiovascular X-Ray Imaging Systems due to a software error that may prevent the system from booting.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
GE Healthcare, LLC is recalling four units of the Discovery IGS 730 Cardiovascular X-Ray Imaging System. The recall is due to a patient data management error that may prevent the system from booting on start-up or re-booting during a procedure. This issue can occur when a large amount of patient data remains in the browser and is not deleted.
The affected systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular, and non-vascular diagnostic and interventional procedures. The recall includes two units in the United States (Pennsylvania and Tennessee) and two units outside the United States (France and Singapore).
The source text does not specify the required corrective actions or the specific steps consumers or healthcare providers should take to address this issue.
The recalled product
- Product
- GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.…
- Manufacturer
- GE Healthcare, LLC
Distribution
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