HIGH

Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

Quick Facts at a Glance

Recall Date
April 14, 2026
Hazard Level
HIGH
Brand
Philips North America
Geographic Scope
1 states

Hazard Information

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America or your healthcare provider for instructions. Notification method: Letter

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Full Description

Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.. Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.. Classification: Class II. Quantity: 1 unit. Distribution: Worldwide - US Nationwide and the countries of 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 Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.

Safety Guide

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Product Classification

Product Details

Model Numbers
1. Model Number (REF): 781278. UDI: (01)00884838004139(21)38103. Serial Numbers: 38103.
Affected States
ALL
Report Date
May 6, 2026
Recall Status
ACTIVE

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