Philips North America: Philips Ingenia Ambition X With Mr Elastography (mre). 1. Model Number (ref): 781356. 2. Model Number (ref): 782109. 3. Model Number (ref): 782138....
Recall Summary Philips is recalling certain Ingenia Ambition X MRI machines (models 781356, 782109, 782138, and 782160) worldwide because a software issue can produce incorrect stiffness measurements when specific imaging settings are used together. The error occurs when the image reconstruction parameters combine with Resoundant's algorithm in a way that causes voxel size settings to display too small in the default scan protocol. This recall affects hospitals and imaging facilities across the United States and numerous countries internationally.
- Recalling firm
- Philips North America
- Product
- Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
- 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/73ec808b-be38-4e95-a189-aa4c1294a43e