The Recall Desk
HighFDA (Devices)·Z-1805-2026·Announced 2026-04-22

Philips AneurysmFlow MAFA ratio does not give reliable prognostic information

Philips is recalling AneurysmFlow because the Mean Aneurysm Flow Amplitude ratio does not reliably predict aneurysm occlusion after flow diverter stent treatment, yet is relied on clinically.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall where a software output relied on for clinical decisions does not provide reliable prognostic information, a risk of harm with no injuries reported.

Plain-English summary

Philips is recalling AneurysmFlow, model number 001015, software version R1.x. AneurysmFlow is a software medical device used with a Philips interventional X-ray system and 3D rotational angiography data. The action covers 1,033 units.

Philips has identified a potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio. The firm has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following flow diverter stent treatment, and although this is stated in the instructions for use, the ratio is being relied on for making clinical decisions. The FDA classified the action as Class II.

Distribution was worldwide, covering the United States nationwide and a large number of international markets. The software is used in hospital interventional suites rather than sold to consumers.

Facilities should identify affected installations using the model number and UDI codes in the recall notice and follow the instructions issued by Philips.

The recalled product

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.
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Interventional software
Hazard
Affected units
1,033

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • (01)00884838099272(21)67
  • (01)00884838099272(21)675
  • (01)00884838085367(21)178
  • (01)00884838099272(21)112
  • (01)00884838085367(21)335
  • (01)00884838116801(21)345
  • (01)00884838085367(21)147
  • (01)00884838085367(21)205
  • (01)00884838099272(21)113
  • (01)00884838099272(21)121
  • (01)00884838116801(21)24
  • (01)00884838085367(21)170
  • (01)00884838099258(21)1150
  • (01)00884838116801(21)17
  • (01)00884838116801(21)25
  • (01)00884838059061(21)639
  • (01)00884838085268(21)856
  • (01)00884838116801(21)180
  • (01)00884838116801(21)227
  • (01)00884838099272(21)239

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

See all →