FDA-Device2024-05-29Class II
Achieva 1.5T Initial system Model Number (REF): 781178
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
2 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Achieva 1.5T Initial system Model Number (REF): 781178
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1838-2024Don't want to check this manually?
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