Philips North America: Philips Ingenia 3.0t With Mr Elastography (mre). 1. Model Number (ref): 781342. 2. Model Number (ref): 781377. 3. Model Number (ref): 782103. 510(k...
Recall Summary Philips is recalling three models of its Ingenia 3.0T MR Elastography machines (model numbers 781342, 781377, and 782103) distributed worldwide because they may produce incorrect stiffness measurements when certain image settings are used together. The error occurs due to how the reconstruction voxel size is configured in the default scan protocol when using Resoundant's algorithm.
- Recalling firm
- Philips North America
- Product
- Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, 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/fc14ceb2-bd57-4902-8460-628b266b6df2