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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98576

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 19, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1805-2026
Recall number
Z-1805-2026
Initiated
March 19, 2026
Classification
Class II
Status
Ongoing
Quantity
1,033 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Number: 001015. Software Version Number R1.x. 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(01)00884838099272(21)770, (01)00884838116801(21)78, (01)00884838099272(21)56, (01)00884838059061(21)344, (01)00884838099258(21)718, (01)00884838059115(21)64, (01)00884838085367(21)94, (01)00884838099272(21)155, (01)00884838099272(21)177, (01)00884838085367(21)66, (01)00884838099272(21)96, (01)00884838099272(21)28, (01)00884838099272(21)560, (01)00884838099272(21)433, (01)00884838085367(21)108, (01)00884838085367(21)200, (01)00884838085367(21)201, (01)00884838099272(21)324, (01)00884838085367(21)189, (01)00884838116801(21)59, (01)00884838059122(21)2, (01)00884838059061(21)522, (01)00884838099272(21)588, (01)00884838085367(21)311, (01)00884838059115(21)272, (01)00884838059115(21)210, (01)00884838116801(21)104, (01)00884838059115(21)243, (01)00884838099272(21)79, (01)00884838116801(21)107, (01)00884838059061(21)394, (01)00884838099272(21)236, (01)00884838059115(21)20, (01)00884838099272(21)863, (01)00884838116801(21)152, (01)00884838099272(21)165, (01)00884838099272(21)402, (01)00884838099272(21)652, (01)00884838085367(21)297, (01)00884838116801(21)153, (01)00884838099272(21)241, (01)00884838059115(21)218. AneurysmFlow is a software medical device intended to be used in combination with the Philips interventional X-ray system (Allura and Azurion systems) and 3DRA data. The Allura and Azurion systems are not impacted by this recall. Since AneurysmFlow is always used with Allura and Azurion systems, below is information of those systems that are currently being used with the affected software to help with identification of the affected devices. The Allura and Azurion model numbers where AneurysmFlow is used are the following: 722006, 722008, 722012, 722013, 722015, 722028, 722068, 722029, 722035, 722038, 722079, 722058, 722226, 722236, 722059, 722224, 722234, 722228, 722282.

Distribution pattern

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.

Field note

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