Philips AneurysmFlow software recalled for unreliable aneurysm flow measurement
Contact Philips about AneurysmFlow software update
Philips AneurysmFlow is software used by doctors to help evaluate aneurysm treatment with flow diverter stents. The software's Mean Aneurysm Flow Amplitude (MAFA) ratio does not reliably predict whether the aneurysm is successfully closed, but doctors may be using it to make treatment decisions based on the user manual.
- If your hospital or clinic uses Philips AneurysmFlow (Model 001015), contact Philips Medical Systems for guidance on this software issue
- Do not rely solely on the MAFA ratio measurement when making clinical decisions about aneurysm treatment
- Review affected patient cases with your clinical team
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1805-2026More PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls
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