Achieva 3.0T, Model No. 781177
FDA Recall #Z-0809-2024 — Class III — December 29, 2023
Product Description
Achieva 3.0T, Model No. 781177
Reason for Recall
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.
Recalling Firm
Philips North America — Cambridge, MA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
7 US; 16 ROW total
Distribution
Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.
Code Information
Model No. 781177 UDI-DI N/A Serial Number 17043
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated