Z-1945-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 18, 2012
- Initiation Date
- May 1, 2012
- Termination Date
- January 31, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 377 units
Product Description
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.
Reason for Recall
There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
Distribution Pattern
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
Code Information
All lots on the market of model 100