Philips Medical Systems Nederland B.V. is recalling 1,033 units of its AneurysmFlow software (Model 001015, Version R1.x), an interventional tool used during brain aneurysm treatments. The company found that the Mean Aneurysm Flow Amplitude (MAFA) ratio provided by the software does not reliably predict whether an aneurysm will successfully close after a stent is placed. Although the instructions for use note this limitation, some clinicians are using this unreliable data to make critical surgical decisions. The software is used with Philips Allura and Azurion X-ray systems, though the X-ray systems themselves are not defective.
If a surgeon relies on incorrect flow data from the software to assess a treatment's success, they may make inappropriate clinical decisions during or after the procedure. This could lead to a patient receiving unnecessary additional treatments or, conversely, failing to receive a needed intervention for an aneurysm that was not actually closed, potentially increasing the risk of aneurysm rupture or stroke.
Used in combination with Philips Allura and Azurion X-ray systems (Models: 722006, 722008, 722012, 722013, 722015, 722028, 722068, 722029, 722035, 722038, 722079, 722058, 722226, 722236, 722059, 722224, 722234, 722228, 722282).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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