Recall Monitor
Health ProductsType I recall

Ingenia and Achieva Systems

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Ingenia and Achieva Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
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Products

Affected productsLot or serial numberModel or catalogue number
Ingenia 1.5T708511.5T
Ingenia Elition X45052781358
Ingenia Elition X45590782107
Ingenia Elition X62158782107
Ingenia Ambition X49004782138
Achieva 3.0T MRI System - Main Unit17385ACHIEVA 3.0T
Achieva 3.0T MRI System - Main Unit38109ACHIEVA 3.0T

Issue

Philips has become aware through the MRE software system developer Resoundant about an issue affecting MRE stiffness measurements when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. Specifically, the reconstruction voxel size settings in the default MRE scan protocol are too small, which can potentially lead to inaccurate liver stiffness measurements (lower values).

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