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Z-1945-2012 Class II Terminated

Recalled by Atom Medical Corporation — Bunkyo-Ku

FDA device recall Z-1945-2012 was initiated by Atom Medical Corporation on May 1, 2012 and is designated Class II. Reason for recall: There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode. The recall status is terminated (terminated January 31, 2013). Affected quantity: 377 units.

Recall Details

Product Type: Devices
Report Date: July 18, 2012
Initiation Date: May 1, 2012
Termination Date: January 31, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 377 units

Product Description

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.

Distribution Pattern

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

Code Information

All lots on the market of model 100