Philips Ingenia 1.5T MRI System Stiffness Value Calculation Error Recall

Plain-English summary

Philips North America is recalling certain Philips Ingenia 1.5T magnetic resonance imaging (MRI) systems equipped with MR Elastography (MRE). The recalled devices include four model numbers (REF 781315, 781341, 781396, and 782115) across multiple 510(k) authorizations. A total of 54 units are affected.

The recall addresses a potential for stiffness value errors that can occur when specific ranges of image reconstruction parameters are used in combination with Resoundant's algorithm. When this combination occurs, the reconstruction voxel size settings in the default MRE scan protocol may display as too small, potentially leading to inaccurate tissue stiffness measurements during elastography imaging.

The affected devices have been distributed worldwide, including throughout the United States and to countries including Canada, Mexico, the United Kingdom, Germany, France, Italy, Spain, Australia, Japan, South Korea, and many others. Facilities using these systems should contact Philips North America for guidance on corrective action.

The recalled product

Product

Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

Manufacturer

Philips North America

Category

Medical Device — Diagnostic Imaging / MRI

Hazard

• measurement-error
• software-defect

Affected units

54

Is your product affected?

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

Distribution

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