Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Reported: February 4, 2026 Initiated: December 3, 2025 #Z-1204-2026
Product Description
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. 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).
Details
- Recalling Firm
- Philips North America
- Units Affected
- 3 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.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.. Recalled by Philips North America. Units affected: 3 units.
Why was this product recalled? ▼
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 4, 2026. Severity: Moderate. Recall number: Z-1204-2026.
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