GE Healthcare Recalls Seno Advantage 2.2 Workstations Due to Scale Factor Errors
GE Healthcare is recalling 12 Seno Advantage 2.2 workstations because inaccurate scale factor annotations may lead to miscalculation of image sizes, potentially impacting patient safety.
What this means for you
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 a risk of harm (miscalculation of size impacting patient safety) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 12 Seno Advantage 2.2 workstations equipped with software versions 22_01 and 22_02. These medical image review stations are used to select, process, and interchange multi-modality images from various diagnostic imaging systems.
The recall is being issued because the workstations provide inaccurate scale factor annotations. This issue may result in a potential miscalculation of size, which the manufacturer states may impact patient safety.
The affected units were distributed worldwide, including nationwide in the United States (specifically in CA, CT, NY, TX, and MS) and in Taiwan, Italy, Canada, and Bahrain. Users of these workstations should contact GE Healthcare for further instructions on correcting the software issue.
The recalled product
- Product
- GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 12
Distribution
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