Philips North America: System, Nuclear Magnetic Resonance Imaging
Recall Summary Philips is recalling three models of Ingenia Elition S MRI machines (model numbers 781357, 782106, and 782137) because they may produce inaccurate stiffness measurements when certain image reconstruction settings are used together with Resoundant's algorithm. The machines are distributed worldwide, including throughout the United States and 50+ other countries. This is a Class II recall, meaning the problem could cause incorrect patient results but is not immediately life-threatening.
- 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
- 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/fd7b9350-63ad-4116-a879-9dcb9f7ab7e9