Health product recall

Ingenia and Achieva Systems

Last updated

Summary

Product
Ingenia and Achieva Systems
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

Ingenia 1.5T

70851

1.5T

Ingenia Elition X

45052

781358

Ingenia Elition X

45590

782107

Ingenia Elition X

62158

782107

Ingenia Ambition X

49004

782138

Achieva 3.0T MRI System - Main Unit

17385

ACHIEVA 3.0T

Achieva 3.0T MRI System - Main Unit

38109

ACHIEVA 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). 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Philips Medical Systems Nederland B.V.
Veenpluis 6, Best, Netherlands, 5684 PC
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Recall date
Identification number
RA-81905

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