PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 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.

Recall number

Z-1805-2026

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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.

Status

Open, Classified

Initiated

2026-03-19

Posted

2026-04-10

Terminated

not on file

Reason

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.

Root 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

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.

Lot, serial or model codes

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.

510(k) numbers

["K160455"]

PMA numbers

not on file

Product code

LLZ

Firm FEI

3002807880

Firm city

Best

Firm state

not on file

Firm country

Netherlands

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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