Philips AneurysmFlow Device Recall Due to Safety Issue
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Philips Medical Systems is recalling 1,033 units of AneurysmFlow software because the Mean Aneurysm Flow Amplitude ratio may not provide reliable prognostic information for aneurysm treatment decisions.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 3, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Philips has initiated a recall for the AneurysmFlow software due to a potential safety issue where the Mean Aneurysm Flow Amplitude (MAFA) ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, which could lead to reliance on inaccurate data for clinical decisions.
Which Products Are Affected
The affected product is Philips AneurysmFlow, Model Number: 001015, with Software Version Number R1.x. A total of 1,033 units are involved, distributed worldwide including US Nationwide and countries such as Argentina, Australia, Austria, and others. Specific UDI Numbers include (01)00884838099272(21)153, (01)00884838099272(21)67, and many more as listed in the recall details. The product is a software medical device intended for use with Philips interventional X-ray systems like Allura and Azurion, though those systems themselves are not impacted.
What You Should Do
Consumers and users should follow the initial firm notification, which was issued via letter, for instructions on how to proceed. Contact the recalling firm, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. at Veenpluis 4-6, Best, Netherlands, for information on returns or further guidance regarding the affected devices.
Why This Matters
This recall highlights potential risks in medical device accuracy that could impact clinical decisions for aneurysm treatments, emphasizing the need for reliable tools in healthcare to ensure patient safety and effective outcomes.
Source
This recall is attributed to the FDA. For more information, visit the FDA website at https://www.fda.gov/ and search for recall number Z-1805-2026.
Original source: FDA Official Notice ↗
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