Device recall

Z-1945-2012: Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15…

FDA device recall · Class II · Atom Medical Corporation

Key facts

Recall number (Z-number) Z-1945-2012
Recall event 61807
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
Recalling firm Atom Medical Corporation
Recall class Class II
Status Terminated
Termination date Jan 31, 2013
510(k) numbers K102226
FEI number 3005652389

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)