Philips North America: Philips Ingenia Elition S With Mr Elastography (mre). 1. Model Number (ref): 781357. 2. Model Number (ref): 782106. 3. Model Number (ref): 782137
Philips is recalling three models of its Ingenia Elition S MRI machines with MR Elastography capability due to potential errors in stiffness measurements when certain image settings are used together. The error occurs because reconstruction voxel size settings in the default scan protocol may display as too small, which could affect the accuracy of tissue stiffness readings. The recall affects machines distributed worldwide, including throughout the United States and numerous other countries.
- Recalling firm
- Philips North America
- Product
- Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-14
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/3a1bb37b-f92a-4468-a761-e40d2b6fc4cf