Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 an...
FDA Recall #Z-1207-2026 — Class II — December 3, 2025
Product Description
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
Reason for Recall
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Recalling Firm
Philips North America — Cambridge, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
24 units
Distribution
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.
Code Information
MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781342; UDI-DI: 00884838055339; Serial Numbers: 71607, 85216, 71087, 71619, 71462, 71002, 71885, 71841, 71378, 71269, 85126, 71279, 71088, 71185, 71532, 71344, 71756, 71336, 71459. (2) Product Code (REF): 781377; UDI-DI: 00884838009813; Serial Numbers: 42305, 42299, 42036, 42376, 42321.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated