CanadaAneurysmFlow software (model/catalogue number 1.4) from Philips Medical Systems Nederland B.V., as identified by Health Canada, is affected; lot or serial number is not applicable. Philips determined the mafa ratio displayed by AneurysmFlow does not provide reliable prognostic information regarding aneurysm occlusion following flow diverter stent treatment and, despite cautions in the instructions for use and an on‑screen message, the displayed mafa ratio may still be considered during intraprocedural decision‑making and could influence clinical judgment, potentially resulting in an incorrect clinical decision. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Philips Medical Systems Nederland B.V., Veenpluis 6, Best, Netherlands, 5684 PC.
How to identify it
Affected products: AneurysmFlow; Lot or serial number: Not applicable.; Model or catalogue number: 1.4
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)