Philips Ingenia 3.0T MRI System with Elastography Software Recall

Plain-English summary

Philips North America is recalling the Philips Ingenia 3.0T with MR Elastography (MRE) across three model numbers (781342, 781377, and 782103). A total of 64 units have been distributed worldwide, including throughout the United States and to 46 additional countries.

The recall addresses a potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. When these conditions occur, the reconstruction voxel size settings in the default MRE scan protocol may display as too small, which could impact the accuracy of elastography measurements.

Affected facilities should contact Philips North America for guidance on this issue. This is a Class II medical device recall as classified by the FDA.

The recalled product

Product

Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

Manufacturer

Philips North America

Category

Medical Device — MRI System / Imaging Equipment

Hazard

• measurement-error
• software-issue

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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