Warning
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recalls Philips AneurysmFlow
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1805-2026Medical Device
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recalls Philips AneurysmFlow
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II — Moderate Risk
Product 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.
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
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.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database