FDA-Device2024-05-29Class II
SmartPath to dStream for 3.0T Model Number (REF): 782145
Philips North America Llc
Hazard
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Sold states
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Affected count
3 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
SmartPath to dStream for 3.0T Model Number (REF): 782145
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1861-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief