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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Event Detail

Event ID 61807
Product Type Devices
Status Ongoing
Recalling Firm Atom Medical Corporation
City Bunkyo-Ku
Country JP
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-01
Initial Firm Notification of
Consignee or Public
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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. All lots on the market of model 100 Class II There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode. 377 units Z-1945-2012