Public recall detail

Ingenia and Achieva Systems

2026-04-16

medium
Radiology Performance
Quick summary

Quick summary: Ingenia and Achieva Systems. Reason: Performance. Category: Radiology. Date: 2026-04-16.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Ingenia and Achieva Systems. Reason: Performance. Category: Radiology. Date: 2026-04-16.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ProductIngenia and Achieva Systems
IssueMedical devices - Performance
Recall classType I
IdentificationRA-81905

Affected products

ProductIngenia 1.5T
Lot70851
Model1.5T
Serial number70851
DescriptionIngenia 1.5T
ProductIngenia Elition X
Lot45052
Model781358
Serial number45052
DescriptionIngenia Elition X
ProductIngenia Elition X
Lot45590
Model782107
Serial number45590
DescriptionIngenia Elition X
ProductIngenia Elition X
Lot62158
Model782107
Serial number62158
DescriptionIngenia Elition X
ProductIngenia Ambition X
Lot49004
Model782138
Serial number49004
DescriptionIngenia Ambition X
ProductAchieva 3.0T MRI System - Main Unit
Lot17385
ModelACHIEVA 3.0T
Serial number17385
DescriptionAchieva 3.0T MRI System - Main Unit
ProductAchieva 3.0T MRI System - Main Unit
Lot38109
ModelACHIEVA 3.0T
Serial number38109
DescriptionAchieva 3.0T MRI System - Main Unit

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).

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
Recall date2026-04-15
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-81905
Background{}
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
AudiencesHealthcare
Source updated2026-04-16

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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