Class II — Atom Medical Corporation
| Recalling firm | Atom Medical Corporation |
|---|---|
| Registered facility | ATOM MEDICAL CORPORATION (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode. |
| Product | 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. |
| Quantity | 377 units |
| Distribution | 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 |
| Initiated | 2012-05-01 |
| Classified | 2012-07-06 |
| Terminated | 2013-01-31 |
| Recall number | Z-1945-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Atom Medical Corporation (Z-1945-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/61807/
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