FDA-Device2023-11-29Class II
SmartPath to dStream for 1.5T
Philips North America Llc
Hazard
Potential component failure in the Gradient Coil could product smoke and/or fire.
Sold states
Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.
Affected count
119 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
SmartPath to dStream for 1.5T
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0395-2024Don't want to check this manually?
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