- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- 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.
- Affected products (lot / model / serial)
- Model Number: 001015. Software Version Number R1.x. UDI Number: (01)00884838099272(21)153, (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, (01)00884838099272(21)105, (01)00884838116801(21)235, (01)00884838099272(21)678, (01)00884838054202(21)373, (01)00884838059115(21)290, (01)00884838085367(21)564, (01)00884838085268(21)716, (01)00884838085367(21)440, (01)00884838116801(21)226, (01)00884838099272(21)197, (01)00884838099272(21)380, (01)00884838059115(21)274, (01)00884838085367(21)247, (01)00884838085367(21)225, (01)00884838099272(21)592, (01)00884838099272(21)593, (01)00884838099272(21)319, (01)00884838099272(21)339, (01)00884838099272(21)182, (01)00884838099258(21)1234, (01)00884838085367(21)64, (01)00884838116801(21)20, (01)00884838099272(21)272, (01)00884838099272(21)680, (01)00884838085367(21)153, (01)00884838099272(21)350, (01)00884838099272(21)280, (01)00884838116801(21)208, (01)00884838116801(21)205, (01)00884838116801(21)36, (01)00884838085367(21)85, (01)00884838085367(21)89, (01)00884838085367(21)320, (01)00884838099272(21)144, (01)00884838085367(21)109, (01)00884838085367(21)407, (01)00884838099272(21)779, (01)00884838116801(21)81, (01)00884838085367(21)505, (01)00884838059115(21)277, (01)00884838099272(21)559, (01)00884838085367(21)443, (01)00884838099272(21)98, (01)00884838099272(21)343, (01)00884838116801(21)147, (01)00884838116801(21)148, (01)00884838085367(21)104, (01)00884838099272(21)876, (01)00884838059115(21)168, (01)00884838099272(21)1021, (01)00884838099272(21)244, (01)00884838116801(21)31, (01)00884838099272(21)332, (01)00884838099272(21)781, (01)00884838099272(21)782, (01)00884838085367(21)524, (01)00884838099272(21)534, (01)00884838099272(21)129, (01)00884838099272(21)442, (01)00884838085367(21)400, (01)00884838059061(21)575, (01)00884838099272(21)189, (01)00884838099272(21)190, (01)00884838085367(21)510, (01)00884838116801(21)252, (01)00884838085367(21)110, (01)00884838099272(21)208, (01)00884838085367(21)73, (01)00884838085367(21)288, (01)00884838085268(21)281, (01)00884838116801(21)21, (01)00884838099272(21)400, (01)00884838085367(21)406, (01)00884838099272(21)326, (01)00884838085367(21)528, (01)00884838099272(21)323, (01)00884838116801(21)118, (01)00884838116801(21)50, (01)00884838085268(21)852, (01)00884838099258(21)101, (01)00884838085367(21)457, (01)00884838085367(21)470, (01)00884838085367(21)472, (01)00884838099272(21)778, (01)00884838116801(21)39, (01)00884838085268(21)704281, (01)00884838085367(21)319, (01)00884838085367(21)520, (01)00884838085367(21)490, (01)00884838085268(21)703418, (01)00884838116801(21)48, (01)00884838099272(21)482, (01)00884838116801(21)221, (01)00884838085367(21)150, (01)00884838099258(21)46, (01)00884838085367(21)172, (01)00884838085268(21)29, (01)00884838059115(21)61, (01)00884838099272(21)793, (01)00884838116801(21)68, (01)00884838085367(21)117, (01)00884838085268(21)930, (01)00884838099272(21)1017, (01)00884838085367(21)130, (01)00884838059115(21)264, (01)00884838099272(21)410, (01)00884838099272(21)508, (01)00884838059115(21)167, (01)00884838099272(21)419, (01)00884838085367(21)469, (01)00884838099272(21)472, (01)00884838059061(21)327, (01)00884838085268(21)21, (01)00884838116801(21)51, (01)00884838099272(21)383, (01)00884838085367(21)76, (01)00884838099272(21)59, (01)00884838099272(21)361, (01)00884838085367(21)477, (01)00884838099272(21)1002, (01)00884838085367(21)137, (01)00884838059061(21)580, (01)00884838116801(21)38, (01)00884838116801(21)22, (01)00884838099272(21)398, (01)008848
- Units affected
- 1,033 units
- 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.
- Firm location
- Best, N/A, Netherlands
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1805-2026
- Recall initiated
- March 19, 2026
- FDA classification date
- April 10, 2026
- FDA report date
- April 22, 2026
- FDA event ID
- 98576
- Last updated on HTM Vibe
- July 24, 2026