GE Healthcare Recalls CardiacVX Software Due to Inaccurate Flow Values
GE Healthcare is recalling CardiacVX and CardiacVX Flow software because it may report flow values higher than actual. The recall affects 101 units distributed worldwide.
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 product (medical device software) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare, LLC is recalling CardiacVX and CardiacVX Flow analysis software, which runs on the Advantage Workstation. The affected software versions are 1.1.0 Ext. d, and the specific model numbers are 5434389-2 and 5434384-2. This software is an analytical tool used for the review and reporting of medical images.
The recall was initiated because GE Healthcare became aware of a potential safety issue where the software may report flow values that are higher than the actual values. This inaccuracy could impact the reliability of the data provided by the tool.
A total of 101 units are affected by this recall, with 1 unit in the United States and 100 units distributed internationally. The software was distributed worldwide, including to Australia, Canada, Chile, France, Italy, Japan, Korea, Kuwait, New Zealand, Panama, Poland, Saudi Arabia, Spain, Sweden, Switzerland, and the United Kingdom. Users of this software should contact GE Healthcare for further instructions regarding the safety issue.
The recalled product
- Product
- GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the revi
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Software
- Hazard
Distribution
Distributed in 1 state:
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