Philips Ingenia Elition X MRI Scanner Recall for Image Reconstruction Error

Plain-English summary

Philips North America is recalling the Ingenia Elition X with MR Elastography (MRE) medical imaging system due to a potential issue with stiffness value errors. The error occurs when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, causing the reconstruction voxel size settings in the default MRE scan protocol to display too small.

The affected devices include Model Numbers REF 781358, REF 782107, and REF 782136, totaling approximately 103 units worldwide. These systems have been distributed in the United States and numerous countries including Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Federation, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, and the United Kingdom.

Patients and healthcare providers with these devices should contact Philips North America for further guidance. The FDA has classified this as a Class II recall. For more information, refer to FDA recall number Z-1963-2026.

The recalled product

Product

Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

Manufacturer

Philips North America

Category

Medical Device — MRI / Diagnostic Imaging

Hazard

• measurement-error
• image-reconstruction-defect

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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