Philips North America: Philips Ingenia 1.5t With Mr Elastography (mre). 1. Model Number (ref): 781315. 2. Model Number (ref): 781341. 3. Model Number (ref): 781396. 4. Mo...
Recall Summary Philips is recalling four models of its Ingenia 1.5T MRI machines with MR Elastography software due to a potential error in stiffness value calculations when certain image reconstruction settings are used together. This error could cause the voxel size settings in the default scan protocol to display incorrectly, potentially affecting the accuracy of scan results. The affected machines have been distributed worldwide, including throughout the United States.
- Recalling firm
- Philips North America
- Product
- Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
- 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
- U.S. Food and Drug Administration
- Recall date
- 2026-04-14
- Status
- Ongoing
- 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 U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/7dca9b15-a32b-4304-b72b-47b827388bb8