Philips North America: Philips Smartpath To Ingenia Elition X With Mr Elastography (mre). 1. Model Number (ref): 782118. 2. Model Number (ref): 782144. 3. Model Number (r...
Philips is recalling three models of SmartPath to Ingenia Elition X MRI machines with MR Elastography technology due to potential errors in stiffness value measurements when certain image reconstruction settings are used. The issue could cause the voxel size settings in the default scan protocol to display incorrectly, affecting measurement accuracy. The recall affects machines distributed worldwide, including throughout the United States and numerous other countries.
- Recalling firm
- Philips North America
- Product
- Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
- 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/dd3e312a-5906-4f76-b35b-fce0f6786701