Philips North America: Philips Ingenia Elition X With Mr Elastography (mre). 1. Model Number (ref): 781358. 2. Model Number (ref): 782107. 3. Model Number (ref): 782136. ...
Philips is recalling three models of Ingenia Elition X MRI machines with MR Elastography due to a software issue that can produce inaccurate stiffness measurements when certain image settings are used. The problem stems from incorrect voxel size settings in the default scan protocol that may appear too small. The affected machines have been distributed nationwide in the U.S. and in numerous countries worldwide.
- Recalling firm
- Philips North America
- Product
- Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
- 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/3e515e07-2a3a-44ae-a049-1cbe8b0a3cb3