Philips Ingenia Ambition X MRI Systems Stiffness Value Error Recall

Plain-English summary

Philips North America is recalling Philips Ingenia Ambition X MRI systems equipped with MR Elastography (MRE) functionality. The recall affects 86 units distributed worldwide, including across the United States and numerous international markets.

The issue involves potential stiffness value errors that can occur when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. When this combination occurs, the reconstruction voxel size settings in the default MRE scan protocol may display settings that are too small, which could lead to incorrect stiffness value calculations and impact diagnostic accuracy.

Affected devices include four model numbers: REF 781356, REF 782109, REF 782138, and REF 782160. Customers who operate these systems should contact Philips North America for guidance on addressing this issue and verifying whether their specific device and settings may be affected.

The recalled product

Product

Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.

Manufacturer

Philips North America

Category

Medical Device — MRI System / Imaging Equipment

Hazard

• measurement-error
• incorrect-reconstruction-parameters

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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