FDA Medical Device Recalls (openFDA)
Atom Medical Corporation: 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
- Recalling firm
- Atom Medical Corporation
- 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.
- Status
- Terminated
- Initiated
- 2012-05-01
- Posted
- 2012-07-06
- Terminated
- 2013-01-31
- Reason
- There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
- Root cause
- Device Design
- Action
- Atom Medical sent an Urgent Field Safety Notice dated May 1, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify all affected product in their inventory and quarantine them until the rework was complete. Customers were also asked to identify any customers to whom they further distributed the product and to contact their customers at once and arrange a time in whcih the filed service technician could perform the rework. Customers were asked to return the Recall Response Forms to Atom Medical (kirautc@atomed.co.jp, tsugino@atomed.co.jp, or matsumoto@atomami.co.jp). All forms should be completed and returned by January 31, 2013. For questions regarding this recall call 512-327-9997.
- 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
- Lot, serial or model codes
- All lots on the market of model 100
- 510(k) numbers
- ["K102226"]
- PMA numbers
- not on file
- Product code
- FMZ
- Firm FEI
- 3005652389
- Firm city
- Bunkyo-Ku
- Firm state
- not on file
- Firm country
- Japan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28