Dual Incu i — Class II medical device recall Z-1945-2012
Terminated recall by Atom Medical Corporation, reported 2012-07-18. There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant
| Recall number | Z-1945-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atom Medical Corporation, Bunkyo-Ku, Japan |
| Recall initiated | 2012-05-01 |
| Classified | 2012-07-06 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2013-01-31 |
| Countries outside the US | AE, AU, CH, CN, CO, CZ, DE, DZ, EG, ES, IL, IR, IT, JP, KR, KW, MY, NL, PH, PL, PT, RU, SA, SK, UA |
| Quantity | 377 units |
| Model numbers | 100 |
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.
Reason for recall
There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1945-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.