Z-0515-06

Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator

Name: Z-0515-06 Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator
Creator: Draeger Medical, Inc.
Published: 2005-12-28
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2005-12-28 / Terminated

FDA source

Draeger Medical, Inc. began a recall of Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator on 2005-12-28. The reason FDA records is "Failure to generate an alarm when an unintended disconnection occurrs". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0515-06
Status: Terminated
Initiated: 2005-12-28
Posted: 2006-02-14
Terminated: 2007-08-07
Recalling firm: Draeger, Inc.
Product: Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Failure to generate an alarm when an unintended disconnection occurrs
FDA root cause: Other
Action: Recalling firm has issued a medical device recall letter to consignees to the attention of the Director, Neonatal Intensive Care Unit via Certified Mail to alert them of additional monitoring requirements if a PEEP setting of less than 2.5 mbar is used
Quantity in commerce: 2261 units
Distribution: Product was shipped to medical facilities nationwide
Product codes and lots: Catalog numbers 8418300, 8411162, 8418002, and 8418000

Product code CBK

K974176Class IIBabylog 8000 PlusDrager, Inc. / cleared 1998-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)