Philips North America: System, Nuclear Magnetic Resonance Imaging
Recall Summary Philips is recalling certain MR 7700 nuclear magnetic resonance imaging systems (model numbers 782120 and 782153) with MR Elastography capability because they may produce incorrect stiffness measurements when specific image reconstruction settings are used. The problem affects systems distributed worldwide, including throughout the United States and numerous other countries. This is classified as a Class II recall, meaning the condition may cause incorrect diagnostic results but is not immediately life-threatening.
- Recalling firm
- Philips North America
- Product
- Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
- 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/a5c03d63-4740-494f-a779-cbb7b1b27bea