Philips North America — SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
⚠️ The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 3, 2025
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.
What's affected?
- Product
- SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
- Lot code
- MR systems with SW version R11.1 and R12.1. Product Code (REF): 782145. UDI-DI: 00884838108684. Serial Numbers: 17385.
Additional details
MR systems with SW version R11.1 and R12.1. Product Code (REF): 782145. UDI-DI: 00884838108684. Serial Numbers: 17385.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1 unit.
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