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U.S. Department of Health and Human Services

Class 2 Device Recall Philips AneurysmFlow

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 Class 2 Device Recall Philips AneurysmFlowsee related information
Date Initiated by FirmMarch 19, 2026
Date PostedApril 10, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1805-2026
Recall Event ID 98576
510(K)NumberK160455 
Product Classification System, image processing, radiological - Product Code LLZ
ProductPhilips 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.
Code Information Model Number: 001015. Software Version Number R1.x. 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FEI Number 3002807880
Recalling Firm/
Manufacturer		 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 4-6
Best Netherlands
Manufacturer 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 2		Labeling design
ActionPhilips 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.
Quantity in Commerce1,033 units
DistributionWorldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bnis insted Us Instas instes, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Estonia, Germany, Greece, Indonesia, Iraq, Italy, Japan, Kuwait, Latvia, Macao, Maldives, Mongolia, Morocco, New Zealand, Nicaragua, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, South Africa, Sri Lanka, Switzerland, TURKEY, Ukraine, Utd.Arab.Emir., Uzbekistan, Vietnam.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LLZ
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