Class 3 Device Recall BirthNet

• Date Initiated by Firm: October 13, 2005
• Date Posted: November 01, 2005
• Recall Status: Terminated 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: 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