Philips AneurysmFlow Device Recall Due to Safety Issue
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,681 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.