Philips AneurysmFlow MAFA ratio does not give reliable prognostic information
Philips is recalling AneurysmFlow because the Mean Aneurysm Flow Amplitude ratio does not reliably predict aneurysm occlusion after flow diverter stent treatment, yet is relied on clinically.
- Product
- Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
- Category
- Medical Device
- Distribution
- Distributed nationwide