GE Seno Advantage Workstation Recalled for Incorrect Magnification Measurements
GE Healthcare is recalling Seno Advantage Workstations because measurement values may be incorrect for magnification images from non-GE digital mammography systems.
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 potential patient safety impacts due to incorrect diagnostic measurements, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 188 units of the Seno Advantage 1.x, 2.0, and 2.1 medical image review stations. The recall is due to a software issue where the workstation may provide incorrect measurement values when applied to magnification images acquired on non-GE digital mammography systems.
The affected units were distributed nationwide in the United States and in numerous countries worldwide, including the United Kingdom, Canada, and Germany. The recall is limited to specific serial numbers listed in the official FDA notice.
The incorrect measurements may impact patient safety if not noticed by the caregiver. GE Healthcare has identified the issue and is taking corrective action. Users of these workstations should check their serial numbers against the recall list and contact GE Healthcare for instructions on how to proceed.
The recalled product
- Product
- GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 188
Distribution
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