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

Recall Z-0809-2024 — Achieva 3.0T, Model No. 781177

U.S. FDA — Device Enforcement · United States · 2023-12-29 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0809-2024
Date of alert
2023-12-29
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Philips North America
Product category
device
Product type
Devices
Reported risk: An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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