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Philips North America recalls Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Recalled February 4, 2026 · FDA recall Z-1208-2026 · Philips North America
Hazard
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). · FDA Class II
Units
6 units
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.
Description
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Product
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Manufacturer(s)
Philips North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →