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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.n see related information
Date Initiated by Firm December 28, 2005
Date Posted February 14, 2006
Recall Status1 Terminated 3 on August 07, 2007
Recall Number Z-0515-06
Recall Event ID 34391
510(K)Number K974176  
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator
Code Information Catalog numbers 8418300, 8411162, 8418002, and 8418000
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Michael A. Kelhart
215-660-2349
Manufacturer Reason
for Recall		 Failure to generate an alarm when an unintended disconnection occurrs
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = CBK and Original Applicant = DRAGER, INC.
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