- Recalling firm
- Philips North America
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- 1. Model Number (REF): 781178. UDI: None. Serial Numbers: 20088.
- Units affected
- 1 unit
- Distribution pattern
- 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.
- Firm location
- Cambridge, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1952-2026
- Recall initiated
- April 14, 2026
- FDA classification date
- April 27, 2026
- FDA report date
- May 6, 2026
- FDA event ID
- 98779
- Last updated on HTM Vibe
- July 23, 2026