Recall Z-0296-05 ยท NOU Continuous, Ventilator, Home Use
Pulmonetic Systems, Inc.
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 1000 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall. (FDA Z-1485-04)
| Date | Dec 8, 2004 (initiated Nov 19, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root 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, 20 |
| Distribution | throughout the United States and to countries such as Germany, Canada, United Kingdom, Australia and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.