FDA Device recall Z-1805-2026

Philips AneurysmFlow

• FDA Device
• Class II
• ongoing
• Published 2026-04-22

On 2026-04-22 the FDA classified a Class II recall of Philips AneurysmFlow by Philips Medical Systems Nederland B V, citing 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 r….

Read the official FDA Device notice

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

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Other recalls by Philips Medical Systems Nederland B V

• Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058
  FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V
• Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and…
  FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V
• Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 72222…
  FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V
• Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10
  FDA Device · Class II · 2026-08-12 · Philips Medical Systems Nederland B V
• Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12
  FDA Device · Class II · 2026-08-12 · Philips Medical Systems Nederland B V

All Philips Medical Systems Nederland B V recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1805-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.