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U.S. Department of Health and Human Services

Class 3 Device Recall BirthNet

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  Class 3 Device Recall BirthNet see related information
Date Initiated by Firm October 13, 2005
Date Posted November 01, 2005
Recall Status1 Terminated 3 on January 17, 2011
Recall Number Z-0115-06
Recall Event ID 33769
510(K)Number K965008  
Product Classification System, Monitoring, Perinatal - Product Code HGM
Product BirthNet OB Data Management System 91861
Code Information All serial numbers involved
Recalling Firm/
Manufacturer		 Spacelabs Medical Incorporated
5150 220th Ave Se
Issaquah WA 98029-6834
For Additional Information Contact Al Van Houdt
425-657-7200 Ext. 5920
Manufacturer Reason
for Recall		 Potential for incorrect weight to be displayed.
FDA Determined
Cause 2		 Other
Action On 10/13/04 the firm sent letters to customers advising of the error, and that software to correct the problem will be released the end of October. Service personnel will install new software.
Quantity in Commerce 44 devices
Distribution Distribution was to 44 medical facilities/hospitals 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 = HGM and Original Applicant = SPACELABS MEDICAL, INC.
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