Philips North America: Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
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- Company / brand
- Philips North America
- Product
- Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-04-14
- Code info
- 1. Model Number (REF): 781262. UDI: (01)00884838068445(21)77144. Serial Numbers: 77144.
- Product quantity
- 1 unit
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Cambridge
- State
- MA
- Country
- United States
- Event id
- 98779
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