Philips North America: Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
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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
- Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
- Reason / hazard
- The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-12-03
- Code info
- MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781341; UDI-DI: 00884838055322; Serial Numbers: 70311, 84560, 84403, 84467, 84462, 70042, 84433. (2) Product Code (REF): 781396; UDI-DI: 00884838009820; Serial Numbers: 41356, 41354, 41370.
- Product quantity
- 10 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Cambridge
- State
- MA
- Country
- United States
- Event id
- 98111
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