GE Healthcare Advantage Workstations Recalled for Incorrect Aorta Measurements
GE Healthcare is recalling Advantage Workstations with Advanced Vessel Analysis due to incorrect aorta measurements and potential issues with PET data loading.
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 with a risk of harm (incorrect diagnostic measurements) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
GE Healthcare, LLC is recalling specific versions of the Advantage Workstation software, including versions 4.2 and 4.3 with Volume Viewer 2, and version 4.4 with Volume Viewer 2 or 3, when provided with Advanced Vessel Analysis (AVA). The recall involves 1,055 units distributed worldwide, including across the United States and numerous international countries.
The recall is due to two identified issues. First, the Aorta analysis protocol and customized protocols may produce incorrect measurements. Second, an internal discovery revealed that when loading PET data into the Volume Viewer, slices may be missing in a PET series. GE Healthcare is asking users not to use the aorta analysis protocol or customized protocols for aneurysms until a new software version is installed.
Healthcare facilities and users of these workstations should stop using the affected protocols immediately. Users should contact GE Healthcare for instructions on installing the corrected software version.
The recalled product
- Product
- GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3)…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 1,055
Distribution
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