GE Healthcare AW Server Recalled for Patient Data Display Error
GE Healthcare is recalling AW Server software due to a defect where patient data from one individual may be displayed in the Results Viewer for a different patient.
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 software defect that risks displaying incorrect patient data, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling 429 units of the AW Server medical software system. The AW Server allows multiple users to remotely access applications and process multimodality DICOM images on a network. The recall covers units distributed worldwide, including the United States and numerous international locations.
The recall is due to a potential safety issue in the Results Viewer component of the software. When the Results Viewer is started with a selected series of a patient, pixel and certain annotation data from a different patient may be displayed in one of the viewports. This issue occurs occasionally when multiple users are simultaneously accessing the Results Viewer.
No specific corrective actions or consumer instructions are provided in the source text. Users of the affected software should monitor for official updates from GE Healthcare regarding software patches or remediation steps.
The recalled product
- Product
- GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 429
Distribution
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