Achieva 1.5T, Model No. 781178, 781196, 781296
FDA Recall #Z-0807-2024 — Class III — December 29, 2023
Product Description
Achieva 1.5T, Model No. 781178, 781196, 781296
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. 781178 UDI-DI N/A Serial Number 20150; Model No. 781196 UDI-DI N/A Serial Nos. 22270 22095 21113; Model No. 781296 UDI-DI 00884838004108 Serial Nos. 33406 33547 32773 32789 32388
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated