FDA-Device2025-06-18Class II
SmartPath to dStream for 1.5T¿; Product Number: 782146;
Philips North America
Hazard
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Sold states
Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.
Affected count
1 unit
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
SmartPath to dStream for 1.5T¿; Product Number: 782146;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1936-2025Don't want to check this manually?
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