Philips North America — 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 14, 2026
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.
What's affected?
- Product
- Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
- Lot code
- 1. Model Number (REF): 781278. UDI: (01)00884838004139(21)38103. Serial Numbers: 38103.
Additional details
1. Model Number (REF): 781278. UDI: (01)00884838004139(21)38103. Serial Numbers: 38103.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1 unit.
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