FDA Device recall Z-1945-2012
Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator…
- FDA Device
- Class II
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class II recall of Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator… by Atom Medical, citing there is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1945-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-01 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Atom Medical |
| Distribution | PA |
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
There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
Identifiers
| code_info | All lots on the market of model 100 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1945-2012%22
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