Philips North America: System, Nuclear Magnetic Resonance Imaging
Philips is recalling certain Ingenia Ambition S MRI machines (models 781359, 782108, and 782139) because they may produce inaccurate stiffness measurements when using specific image reconstruction settings with MR Elastography. The affected machines are distributed worldwide, including throughout the United States and numerous other countries. This is a Class II recall, meaning the problem could result in incorrect diagnostic information but is not immediately life-threatening.
- Recalling firm
- Philips North America
- Product
- Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
- 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
- FDA-DEVICES
- Recall date
- 2026-04-14
- Status
- Open, Classified
- 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 FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6f7068c3-2600-4456-9939-0d58d3edac63