GE Healthcare recalls READY View fMRI software due to incorrect maps
GE Healthcare is recalling READY View software because it may compute and display incorrect fMRI activation maps.
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. The hazard involves incorrect medical imaging data, which is a risk-of-harm product issue where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling the Advantage Workstation READY View Application, an image analysis software product. The recall involves 318 units distributed worldwide, including the United States and numerous international locations.
The recall was initiated because the software may compute and display incorrect functional magnetic resonance imaging (fMRI) activation maps when analyzing fMRI images. This defect could result in inaccurate data being presented to users.
No specific consumer action instructions are provided in the source text. Users of the affected software should refer to the official FDA recall notice for specific remediation steps.
The recalled product
- Product
- GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Software
- Hazard
Distribution
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