Z-1485-04

The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of...

Name: Z-1485-04 The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of...
Creator: Cardinal Health 203, Inc
Published: 2004-09-08
License: https://open.fda.gov/license/

Pulmonetic Systems, Inc. / initiated 2004-09-08 / Terminated

FDA source

Cardinal Health 203, Inc began a recall of The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a... on 2004-09-08. The reason FDA records is "Ventilators have not consistently switched to internal battery operation when the external DC power source has become inadequate to supply stable power. This situation results in loss of ventilation to the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1485-04
Status: Terminated
Initiated: 2004-09-08
Posted: 2004-09-28
Terminated: 2008-05-28
Recalling firm: Pulmonetic Systems, Inc.
Product: The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for use by personnel under the direction of a physician. The ventilator is suitable for use in institutional, home and transport settings.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Ventilators have not consistently switched to internal battery operation when the external DC power source has become inadequate to supply stable power. This situation results in loss of ventilation to the patient.
FDA root cause: Other
Action: A letter titled "Important Safety Information", dated September 7, 2004, was issued to all affected customers alerting them to the possibility of ventilator failure and providing instructions for recognizing and responding to the situation.
Quantity in commerce: 10,299 ventilators
Distribution: Nationwide and worldwide
Product codes and lots: Recalled ventilators were manufactured prior to September 2003. Models LTV 1000, 950, 900, and 900 Model contain serial numbers less than A006500, C07000, B03500, and D01400, respectively.

Product code CBK

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)