Atom Medical Corporation recalls Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033

Recalled July 18, 2012 · FDA recall Z-1945-2012 · Atom Medical

Hazard

There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode. · FDA Class II

Units

377 units

Sold at

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

Description

There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.

Product

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.

Manufacturer(s)

Atom Medical Corporation

Made in

Japan

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →