Philips North America: System, Nuclear Magnetic Resonance Imaging
Recall Summary Philips is recalling its Upgrade to MR 7700 with MR Elastography system (Model 782130) because certain image reconstruction settings can cause incorrect stiffness measurements. The issue affects MRI machines with this upgrade that are using specific combinations of reconstruction parameters and Resoundant's algorithm. The recall applies to machines distributed nationwide in the U.S. and in numerous countries worldwide.
- Recalling firm
- Philips North America
- Product
- Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
- 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/da550556-d06d-40fb-a546-9f91443cf4d3