Device recall

Z-0515-06: Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous…

FDA device recall · Class II · Draeger Medical, Inc.

Key facts

Recall number (Z-number) Z-0515-06
Recall event 34391
Product Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator
Product code CBK
Recalling firm Draeger Medical, Inc.
Recall class Class II
Status Terminated
Termination date Aug 7, 2007
510(k) numbers K974176
FEI number 2517967

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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

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