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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

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

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 Letter
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