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U.S. Department of Health and Human Services

Class 2 Device Recall Babylog 8000 plus with software version 5.n

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 Class 2 Device Recall Babylog 8000 plus with software version 5.nsee related information
Date Initiated by FirmDecember 28, 2005
Date PostedFebruary 14, 2006
Recall Status1 Terminated 3 on August 07, 2007
Recall NumberZ-0515-06
Recall Event ID 34391
510(K)NumberK974176 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
ProductBabylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator
Code Information Catalog numbers 8418300, 8411162, 8418002, and 8418000
FEI Number 2517967
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information ContactMichael A. Kelhart
215-660-2349
Manufacturer Reason
for Recall		Failure to generate an alarm when an unintended disconnection occurrs
FDA Determined
Cause 2		Other
ActionRecalling 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 Commerce2261 units
DistributionProduct was shipped to medical facilities nationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = CBK
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