Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interv...
FDA Device Recall #Z-1805-2026 — Class II — March 19, 2026
Recall Summary
| Recall Number | Z-1805-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 19, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Location | Best, N/A |
| Product Type | Devices |
| Quantity | 1,033 units |
Product Description
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.
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.
Distribution Pattern
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.
Lot / Code Information
Model Number: 001015. Software Version Number R1.x. 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(01)00884838099272(21)770, (01)00884838116801(21)78, (01)00884838099272(21)56, (01)00884838059061(21)344, (01)00884838099258(21)718, (01)00884838059115(21)64, (01)00884838085367(21)94, (01)00884838099272(21)155, (01)00884838099272(21)177, (01)00884838085367(21)66, (01)00884838099272(21)96, (01)00884838099272(21)28, (01)00884838099272(21)560, (01)00884838099272(21)433, (01)00884838085367(21)108, (01)00884838085367(21)200, (01)00884838085367(21)201, (01)00884838099272(21)324, (01)00884838085367(21)189, (01)00884838116801(21)59, (01)00884838059122(21)2, (01)00884838059061(21)522, (01)00884838099272(21)588, (01)00884838085367(21)311, (01)00884838059115(21)272, (01)00884838059115(21)210, (01)00884838116801(21)104, (01)00884838059115(21)243, (01)00884838099272(21)79, (01)00884838116801(21)107, (01)00884838059061(21)394, (01)00884838099272(21)236, (01)00884838059115(21)20, (01)00884838099272(21)863, (01)00884838116801(21)152, (01)00884838099272(21)165, (01)00884838099272(21)402, (01)00884838099272(21)652, (01)00884838085367(21)297, (01)00884838116801(21)153, (01)00884838099272(21)241, (01)00884838059115(21)218. 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.
Other Recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2258-2026 | Class II | Azurion system; System Code Description (Model ... | Apr 30, 2026 |
| Z-2259-2026 | Class II | Allura system; System Code Description (Model N... | Apr 30, 2026 |
| Z-2225-2026 | Class II | Philips Azurion systems not configured with an ... | Apr 28, 2026 |
| Z-2228-2026 | Class II | Allura system; System Code Description (Model N... | Apr 28, 2026 |
| Z-2229-2026 | Class II | Integris-Allura system; System Code Description... | Apr 28, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.