Class 1 Device Recall Pulmonetic System Universal Cable Adaptor for use on LTV Series Ventilator, Model 950

• Date Initiated by Firm: November 19, 2004
• Date Posted: December 08, 2004
• Recall Status: Terminated on December 13, 2005
• Recall Number: Z-0294-05
• Recall Event ID: 30514
• 510(K)Number: K043029
• Product Classification: Continuous, Ventilator, Home Use - Product Code NOU
• Product: Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 950 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall. (FDA Z-1485-04)
• Code Information: all Universal Cable Adapters identified on outer packaging as part no. 17820-001 and distributed between 11/02/04 and 11/08/04.
• Recalling Firm/ Manufacturer: Pulmonetic Systems, Inc.; 17400 Medina Rd Ste 100; Minneapolis MN 55447-1341
• For Additional Information Contact: Pulmonetic Systems' Technical Support; 800-754 Ext. 1914
• Manufacturer Reason for Recall: Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.
• FDA Determined Cause: Other
• Action: Beginning November 19, 2004 consignees who received the Universal Cable Adaptors (UCA) as correction to the voluntary November 1, 2004 Class I Recall were notified by telephone to discontinue installation of adaptors in stock. A Universal Cable Adaptor Recall Notification will be distributed by Certified Mail on or about November 30, 2004 providing instruction to remove the UCA and instruct consignees to follow November 1, 2004 recall interim instructions. Additionally, all consignees will receive instructions (on December 7, 2004) on how to return any device affected by the November 1, 2004 Recall for a power board replacement at a Pulmonetic systems, Inc. authorized service center.
• Distribution: throughout the United States and to countries such as Germany, Canada, United Kingdom, Australia and Japan
• 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.