Z-1805-2026Class II
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool)...
Philips Medical Systems Nederland B.V. / initiated 2026-03-19 / Open, Classified / root cause: labeling and UDI
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1805-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- 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.
- Product code
- LLZ System, Image Processing, Radiological
- 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.
- Root cause tag
- labeling and UDI
- FDA 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 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.
- Product codes and lots
- 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.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1805-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.