GE Healthcare Recalls Seno Advantage Workstations Due to Patient Mismatch Risk
GE Healthcare is recalling 179 Seno Advantage workstations because a software issue may cause patient mismatch without a warning message, potentially impacting patient safety.
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 (patient mismatch) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare, LLC is recalling 179 units of the Seno Advantage medical image review station. The recall is due to a potential software issue where patient mismatch could occur without a warning message under certain circumstances. This issue may impact patient safety.
The affected workstations are distributed worldwide, including nationwide in the United States and in various international locations such as Canada, Germany, and Japan. The specific serial numbers of the affected units are listed in the recall documentation.
Healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue. Consumers are not directly affected as this is a professional medical device used in clinical settings.
The recalled product
- Product
- GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is a medical image review station that allows easy selection, processing…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 179
Distribution
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