Recall Z-1945-2012— Atom Medical Corporation

Name: FDA recall Z-1945-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-01

Class II · Terminated

Class II FDA medical device recall by Atom Medical Corporation, initiated 2012-05-01, terminated 2013-01-31. It names one FDA 510(k) clearance: K102226. 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..

Recalling firm: Atom Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-05-01
Terminated: 2013-01-31
Firm location: Bunkyo-Ku, Japan

510(k) clearances named in this recall

1 on FDA's record

K102226 — DUAL INCU IAtom Medical Corporation·cleared 2011-01-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.