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

Recall Z-1239-2025 — SIGNA Creator, SIGNA Explorer, NMRI systems

U.S. FDA — Device Enforcement · China · 2025-01-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1239-2025
Date of alert
2025-01-31
Country / jurisdiction
China
Risk level
Class II
Risk type
recall
Brand
GE Healthcare (China) Co., Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00195278577221
Reported risk: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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