# FDA recall Z-1805-2026

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2026-03-19.

## 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.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1805-2026
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-19
- **Report date:** 2026-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Best, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1805-2026

## Citation

> AI Analytics. FDA recall Z-1805-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1805-2026. Source: US FDA. Licensed CC0.

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