Recall Monitor
Health Products

AneurysmFlow

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: AneurysmFlow
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Get told about the next health product recall.

We email or text you when Canada issues a recall that matches what you watch: a brand, a product, an allergen. Most never make the news.

Get health product recall alerts

CA$3.99/mo · cancel anytime

Products

Affected productsLot or serial numberModel or catalogue number
AneurysmFlowNot applicable.1.4

Issue

Philips has determined that the mafa ratio does not provide reliable prognostic information regarding aneurysm occlusion following flow diverter stent treatment. the instructions for use (IFU) of AneurysmFlow state that the mafa ratio should not be used for making clinical decisions (section 9.2 measuring flow). In addition, when hovering over the mafa ratio header within the software interface, an on-screen message states that the mafa ratio is not to be used for clinical decision making. despite the existing cautions, the displayed mafa ratio may still be considered during intraprocedural decision-making and could influence clinical judgment. This may potentially result in an incorrect clinical decision.

Get told about the next health product recall.
Get health product recall alerts

CA$3.99/mo · cancel anytime