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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