Philips North America: System, Nuclear Magnetic Resonance Imaging
Summary Philips is recalling Achieva 1.5T MRI systems with MR Elastography due to potential errors in stiffness measurements when certain image settings are used together, which can cause the scan protocol to display incorrect voxel size settings. The recall affects these systems distributed worldwide, including across all U.S. states and numerous countries. This is a Class II recall, indicating a situation where use of the device may cause adverse health consequences, but not death.
- Recalling firm
- Philips North America
- Product
- Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
- 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/2542a992-39e3-490e-8be8-17a46e4d5cb2