FDAFDA · Food and drugs·Recall number Z-1945-2012
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.
Published July 18, 2012 · Recall initiated: May 1, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Atom Medical Corporation
- Distributor
- 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
- Lot
- All lots on the market of model 100
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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