Philips North America: Philips Ingenia 3.0t Cx With Mr Elastography (mre). 1. Model Number (ref): 781271. 2. Model Number (ref): 782105. 510(k) Numbers: K173079, K183063,...
Recall Summary Philips is recalling certain Ingenia 3.0T CX MRI machines (models 781271 and 782105) worldwide because specific imaging settings can cause measurement errors in elastography scans, resulting in incorrect voxel size calculations. These affected MRI machines are used in medical facilities across the US and numerous countries for diagnostic imaging. This is classified as a Class II recall, indicating a potential for serious health consequences.
- Recalling firm
- Philips North America
- Product
- Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: 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/94215145-ffef-483a-bc0e-b996eecff83c