Philips AneurysmFlow software recalled for unreliable aneurysm flow measurement
Philips AneurysmFlow is software used by doctors to help evaluate aneurysm treatment with flow diverter stents. The software's Mean Aneurysm Flow Amplitude (MAFA) ratio does not reliably predict whether the aneurysm is successfully closed, but doctors may be using it to make treatment decisions based on the user manual.
From the FDA notice · Read the official notice ↗ · All Philips recalls
What to do
- If your hospital or clinic uses Philips AneurysmFlow (Model 001015), contact Philips Medical Systems for guidance on this software issue
- Do not rely solely on the MAFA ratio measurement when making clinical decisions about aneurysm treatment
- Review affected patient cases with your clinical team
Is yours affected?
Compare your label or packaging with 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.
- Sold in
- Nationwide
- Made for
- Adults
Details
- Units affected
- 1,033 units
- Illnesses reported
- None reported
- Manufactured in
- Veenpluis 4-6, N/A, Best, N/A, Netherlands
- Classification
- Class II
- Recall number
- Z-1805-2026
In the FDA's words
- Description
- 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. 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. 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)00884838085367(21)107, (01)00884838116801(21)186, (01)00884838099272(21)75, (01)00884838054202(21)534, (01)00884838085268(21)255, (01)00884838116801(21)32, (01)00884838085367(21)282, (01)00884838099258(21)2557, (01)00884838099272(21)786, (01)00884838116801(21)276, (01)00884838099272(21)19, (01)00884838099272(21)1125, (01)00884838085367(21)487, (01)00884838099272(21)814, (01)00884838085367(21)213, (01)00884838099272(21)469
- Hazard
- 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.
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