Philips North America: System, Nuclear Magnetic Resonance Imaging
Recall Summary Philips is recalling certain Ingenia 3.0T CX magnetic resonance imaging (MRI) machines with MR Elastography capability because they can produce inaccurate stiffness measurements when specific image reconstruction settings are used. The issue affects two model numbers (781271 and 782105) distributed worldwide, including across all U.S. states and numerous countries. This is a Class II recall, meaning there is potential for adverse health effects but not an immediate serious threat.
- 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
- 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/65335f10-aee2-4848-81f4-1cffd4856ce8