FDA-Device2012-07-18Class II
Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
Atom Medical Corporation
Hazard
There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
Sold states
Worldwide Distribution - USA including PA. Internationally to Japan, Kuwait, Saudi Arabia, Lenanon, Italy, Spain, China, East Europe, Slovakia, Poland, Czech Republic, Ukraine, Egypt, Russia, Algeria, Colombia, Germany, Malaysia, Switzerland, Australia, Europe, Portugal, Iran, Israel, Philippines, UAE, Korea, and Netherlands
Affected count
377 units
Manufactured in
3-18-15 Hongo, Bunkyo-Ku, Japan
Products
Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1945-2012Don't want to check this manually?
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