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Philips AneurysmFlow Software Class II Recall - Model 001015

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Summary

FDA initiated Class II recall Z-1805-2026 for Philips AneurysmFlow software (Model 001015, Software Version R1.x), a radiological image processing system intended for use with Philips interventional X-ray systems and 3DRA data. The firm initiated the recall on March 19, 2026. Affected products include numerous UDI numbers spanning multiple product codes.

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FDA issued Class II recall Z-1805-2026 for Philips AneurysmFlow software (Model 001015, Software Version R1.x), a radiological image processing system classified under Product Code LLZ. The recall affects units identified by multiple UDI numbers across various product codes. The firm initiated the recall on March 19, 2026, and the recall status is currently Open and Classified.

Healthcare providers and facilities using Philips AneurysmFlow software Model 001015 should verify their inventory against the listed UDI numbers to determine if affected units are in use. Medical device manufacturers distributing or maintaining this software should coordinate with Philips regarding the recall and any corrective actions required under FDA medical device reporting regulations.

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Apr 16, 2026

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Class 2 Device Recall Philips AneurysmFlow

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| | Class 2 Device Recall Philips AneurysmFlow | |

Date Initiated by Firm March 19, 2026
Date Posted April 10, 2026
Recall Status Open , Classified
Recall Number Z-1805-2026
Recall Event ID 98576
510(K)Number K160455
Product Classification System, image processing, radiological - Product Code LLZ
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. |
| Code Information | Model Number: 001015. Software Version Number R1.x. 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AneurysmFlow is a software medical device intended to be used in combination with the Philips interventional X-ray system (Allura and Azurion systems) and 3DRA data. The Allura and Azurion systems are not impacted by this recall.

Since AneurysmFlow is always used with Allura and Azurion systems, below is information of those systems that are currently being used with the affected software to help with identification of the affected devices. The Allura and Azurion model numbers where AneurysmFlow is used are the following: 722006, 722008, 722012, 722013, 722015, 722028, 722068, 722029, 722035, 722038, 722079, 722058, 722226, 722236, 722059, 722224, 722234, 722228, 722282. |
| 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 | Labeling design |
| Action | 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. |
| Quantity in Commerce | 1,033 units |
| Distribution | Worldwide 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 Cycle | TPLC 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) Database | 510(K)s with Product Code = LLZ |

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Classification

Agency
FDA
Filed
March 19th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Recall Number Z-1805-2026
Docket
K160455

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device recall Software medical device Radiological imaging
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Product Safety

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