Medical Device Recall: SmartPath to dStream for 1.5T, Model No. 781260, 782112
Philips North America · December 29, 2023
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.
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.
States Affected
NATIONWIDE
Quantity Affected
7 US; 16 ROW total
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0812-2024
Status: ongoing
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