CLASS II Device recall · Reported 18 Jul 2012 · FDA Enforcement Report

Dual Incu i, (Atom Infant Incubator recalled by Atom Medical

Atom Medical is recalling Dual Incu i, (Atom Infant Incubator, distributed nationwide in the US. The recall was initiated on 1 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots on the market of model 100

Quantity recalled377 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1945-2012
FDA event ID: 61807
Recalling firm: Atom Medical, Bunkyo-Ku
Classification: Class II
Status: Terminated
Recall initiated: 1 May 2012
FDA classified: 6 Jul 2012
Reported: 18 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

1 May 2012	Recall initiated by company
6 Jul 2012	Classified by FDA	+66 days
18 Jul 2012	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Pennsylvania

Questions about this recall

Is Dual Incu i, (Atom Infant Incubator recalled?

Yes. Atom Medical recalled Dual Incu i, (Atom Infant Incubator on 1 May 2012. The recall is Class II and its status is Terminated. Recall number Z-1945-2012.

Why was it recalled?

There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.

Which lots are affected?

All lots on the market of model 100

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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