Pulmonetic Systems, Inc. Universal Cable Adaptor (Part #17765-001 and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV series Ventilator, Model 800 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall (FDA Z-1485-04). Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.