GE Healthcare Recalls Advantage Workstation Volume Viewer Software
GE Healthcare is recalling Advantage Workstation Volume Viewer software due to potential safety issues that may result in incorrect views and measurements.
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, and the hazard involves incorrect medical measurements which poses a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
GE Healthcare, LLC is recalling specific versions of its Advantage Workstation software, including Volume Viewer Plus 5.x, Volume Viewer 3.x, and Volume Analysis versions 4.0 and 3.1. The recall involves 363 units of the Advantage Windows Volume Rendering Option, which is intended to provide fast, easy, volume visualization of three-dimensional structures imaged with computed tomography (CT) or magnetic resonance (MR) systems.
The recall was initiated because GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus, and Volume Analysis. These issues may result in incorrect views and measurements of patient data. The affected software is dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning.
The affected units were distributed worldwide, including in the United States and numerous international countries. The source text does not specify the exact corrective actions consumers or healthcare providers should take, nor does it report any specific injuries or illnesses associated with the defect.
The recalled product
- Product
- GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast,
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 363
Distribution
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