Philips North America: System, Nuclear Magnetic Resonance Imaging
Recall Summary Philips is recalling certain Achieva 1.5T MRI machines (models 781196 and 781296) distributed worldwide because software settings can cause incorrect stiffness measurements when using MR Elastography, a specialized imaging technique. The error occurs when specific image reconstruction parameters are combined with Resoundant's algorithm, resulting in voxel size settings that display too small. This recall affects hospitals and imaging centers in the United States and numerous countries internationally.
- Recalling firm
- Philips North America
- Product
- Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
- 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/66dab3bf-89ef-45fd-93ab-32343696fd23