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 |
| State | |
| 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 |
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 |
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