Z-1945-2012Class II

Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo...

Name: Z-1945-2012 Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo...
Creator: Atom Medical Corporation
Published: 2012-05-01
License: https://open.fda.gov/license/

Atom Medical Corporation / initiated 2012-05-01 / Terminated / root cause: design

FDA source

Atom Medical Corporation began a 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 for infants on 2012-05-01. FDA classified it as Class II and gives the reason as "There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1945-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-01
Posted: 2012-07-06
Terminated: 2013-01-31
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.
Product code: FMZ Incubator, Neonatal
Reason for recall: There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
Root cause tag: design
FDA 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 ([email protected], [email protected], or [email protected]). All forms should be completed and returned by January 31, 2013. For questions regarding this recall call 512-327-9997.
Quantity in commerce: 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
Product codes and lots: All lots on the market of model 100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1945-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1945-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06

Product code FMZ

K102226Class IIDual Incu IAtom Medical Corporation / cleared 2011-01-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)