Ingenia Ambition X, Model No. 782109
FDA Recall #Z-0810-2024 — Class III — December 29, 2023
Product Description
Ingenia Ambition X, Model No. 782109
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. 782109 UDI-DI 00884838098350 Serial Number 47785
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated