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.
Reason for recall: 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. 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 Quantity: 3 units Lot/code info: 1. Model Number (REF): 782143. UDI: (01)00884838108660(21)42218, (01)00884838108660(21)42225. Serial Numbers: 42218, 42225. 2. Model Number (REF): 782162. UDI: (01)00884838115736(21)71403. Serial Numbers: 71403.
00884838108660, 00884838115736
Official record: FDA (Device enforcement) ↗
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