Philips North America: Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
Read the official notice at FDA (device) →
Get alerts for Philips North America
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Philips North America
- Product
- Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- 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, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.
- Recall initiated
- 2026-04-14
- Code info
- 1. Model Number (REF): 781178. UDI: None. Serial Numbers: 20088.
- Product quantity
- 1 unit
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Cambridge
- State
- MA
- Country
- United States
- Event id
- 98779
Free daily digest + "My products" watchlist