Recall Z-1805-2026

Reason for recall

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.

FDA-determined cause: Labeling design

Action taken

Philips notified consignees on about 03/19/2026 via "URGENT Medical Device Correction" letter. Consignees were instructed NOT to use the MAFA ration for clinical decision making as indicated in the IFU and that AneurysmFlow may continue to be used in accordance with the Instructions for Use (IFU). Additionally, consignees were instructed to circulate the URGENT Medical Device Correction letter to all users so that they are aware of the issue and keep this URGENT Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure the letter is in a place likely to be seen/viewed. Lastly, consignees were instructed to complete and return the response form. In case the Philips interventional X-ray system on which AneurysmFlow is installed has been transferred to another organization, consignees were requested to send a copy of the URGENT Medical Device Correction letter to that organization and inform Philips about this transfer through their local Philips representative. Philips is developing a software update to remove the MAFA ratio from AneurysmFlow. Philips expects to release this software update in December 2026. Local Philips representatives will contact consignees to schedule implementation of this software update once available.