Philips North America: System, Nuclear Magnetic Resonance Imaging
Recall Summary Philips is recalling its Ingenia 1.5T CX magnetic resonance imaging (MRI) system with MR Elastography capability due to potential errors in stiffness measurements when certain image settings are used together. The error occurs because reconstruction voxel size settings in the default scan protocol may display as too small. This recall affects systems distributed worldwide, including all U.S. states and territories, as well as numerous international locations.
- Recalling firm
- Philips North America
- Product
- Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
- 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/29ca90ef-5d83-4167-a15f-0da41293a94e