FDA recall, , Moderate risk
Philips AneurysmFlow
Philips AneurysmFlow software may not provide reliable prognostic information about aneurysm occlusion after Flow Diverter Stent treatment.
Summary by Recall Canary from the FDA notice
What happened
Philips Medical Systems Nederland B.V. is recalling its AneurysmFlow software medical device, model number 001015, because the Mean Aneurysm Flow Amplitude (MAFA) ratio may not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment.
The company determined that, despite being stated in the IUF, it is being relied on for making clinical decisions. The recall involves 1,033 units and was initiated on March 19, 2026, with the FDA adding it to the Enforcement Report on April 10, 2026.
The device is intended for use with a Philips interventional X-ray system and 3DRA data. Distribution is worldwide, including the US nationwide and numerous other countries such as Argentina, Australia, Canada, Germany, Japan, and Turkey. The recall was classified by the FDA on April 10, 2026, and included in the FDA's weekly enforcement report on April 22, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Philips AneurysmFlow.
- Model
- 001015
- UDI-DI
- 00884838099272
- 00884838085367
- 00884838116801
- 00884838099258
- 00884838059061
- 00884838085268
- 00884838054202
- 00884838059115
- 00884838054226
- 00884838116771
- 00884838059054
- 00884838059122
- 00884838054219
- 00884838110571
- 00884838099234
- 00884838054240
Recall details
- Company began the recall
- Sold in
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.
- Company
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, Netherlands
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98576
- Recall number
- Z-1805-2026
- Quantity recalled
- 1,033 units
All recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
