GE Healthcare Recalls CT Scanners Due to Head Scan Software Artifact
GE Healthcare is recalling Optima CT580 and Discovery CT590RT scanners running software version 13BW16.3 because a software issue may cause artifacts that hide pathology during head scans.
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 is classified as FDA Class II, and the hazard involves a risk of harm (hiding pathology) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling 33 units of Optima CT580 and Discovery CT590RT Computed Tomography (CT) scanners. The affected units are running software version 13BW16.3. These scanners are intended to produce cross-sectional images of the body for patients of all ages.
The recall is due to a potential safety issue associated with the Head Scan Protocols. A software issue may cause a novel and rare artifact during a CT head scan when using the head and large head SFOV with the Iterative Bone Option (IBO). This artifact may hide pathology, creating a potential hazardous situation.
The affected units were distributed worldwide, including in the United States (Colorado, Indiana, Massachusetts, New Jersey, North Carolina, Ohio, Pennsylvania, Texas, and Virginia) and in Algeria, France, Germany, Poland, Russia, and Taiwan. Users should contact GE Healthcare for instructions on how to address the software issue.
The recalled product
- Product
- GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — CT Scanner
Distribution
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