FDA-Device2024-01-31Class III
Achieva 1.5T, Model No. 781178, 781196, 781296
Philips North America
Hazard
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.
Sold states
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.
Affected count
7 US; 16 ROW total
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Achieva 1.5T, Model No. 781178, 781196, 781296
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0807-2024Don't want to check this manually?
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