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

Recall Z-1864-2024 — Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361

U.S. FDA — Device Enforcement · United States · 2024-05-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1864-2024
Date of alert
2024-05-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America Llc
Product category
device
Product type
Devices
Reported risk: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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