Z-0294-05

Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for...

Name: Z-0294-05 Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for...
Creator: Pulmonetic Systems, Inc.
Published: 2004-11-19
License: https://open.fda.gov/license/

Pulmonetic Systems, Inc. / initiated 2004-11-19 / Terminated

FDA source

Pulmonetic Systems, Inc. began a recall of Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series... on 2004-11-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0294-05
Status: Terminated
Initiated: 2004-11-19
Posted: 2004-12-08
Terminated: 2005-12-13
Recalling firm: Pulmonetic Systems, Inc.
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)
Product code: NOU Continuous, Ventilator, Home Use
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 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, 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
Product codes and lots: all Universal Cable Adapters identified on outer packaging as part no. 17820-001 and distributed between 11/02/04 and 11/08/04.

Product code NOU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)