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MEDICAL DEVICE RECALLMODERATE

Philips AneurysmFlow Software

Philips is recalling AneurysmFlow software because the MAFA ratio provides unreliable prognostic data for aneurysm treatment decisions.

What to do

Healthcare providers should stop using the MAFA ratio for clinical decision-making and refer to the updated instructions provided by Philips. Contact your local Philips representative for further guidance.

Recalled
Listed
Updated
Recall No.
Z-1805-2026
Agency
FDA
Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall ID
98576
Status
ONGOING

Recall at a glance

Quantity recalled
1,033 units

Why it was recalled

Philips is recalling the AneurysmFlow interventional tool software because the Mean Aneurysm Flow Amplitude (MAFA) ratio does not provide reliable prognostic information for aneurysm occlusion following flow diverter stent treatment. Despite instructions in the user manual, the MAFA ratio is being relied upon for clinical decision-making, which may lead to incorrect treatment assessments.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Philips AneurysmFlow.

Model
001015

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification