Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1207-2026 — Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.

U.S. FDA — Device Enforcement · United States · 2025-12-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1207-2026
Date of alert
2025-12-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838055339
Reported risk: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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