Health product recall

AneurysmFlow

Last updated

Summary

Product
AneurysmFlow
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
AneurysmFlow Not 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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Philips Medical Systems Nederland B.V.

Veenpluis 6, Best, Netherlands, 5684 PC

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81836

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