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U.S. Department of Health and Human Services

Medical Devices

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Pulmonetic Systems LTV Series of Ventilators, Universal Cable Adaptor

Class I Recall
Date Recall
Initiated:
November 19, 2004
Product:
Pulmonetic Systems Universal Cable Adaptor for use on LTV Series Ventilator. Approximately 1129 adaptors have been distributed.
Use:
LTV Series Ventilators are intended to provide continuous or intermittent breathing support for adult or pediatric patients who require mechanical ventilation. The adaptors were designed as a permanent field correction to an earlier Class I recall, Z-1485-04, due to failure of the ventilator to properly switch to using the internal battery when the external power source was unstable or inadequate, resulting in a loss of ventilation.
Recalling Firm:
Pulmonetic Systems, Inc.
17400 Medina Road, Suite 100
Minneapolis , MN 55447-1341
Reason for Recall:
The Universal Cable Adaptor intended to correct an earlier Class I recall of LTV series ventilators, Z-1485-04, is not functioning as intended. The adaptor may not allow the ventilator to be powered up again if the ventilator's internal battery has been depleted or may not be securely attached to the pigtail connector on the ventilator.
Public Contact:
Pulmonetic Systems, Inc.
1-800-754-1914, extension 2
FDA District:
Minneapolis
FDA Comment:

Customers have been asked by the firm to remove the adaptors according to instructions provided to them and return the adaptors to the company.

Pulmonetic Systems' permanent resolution of the ventilator's power switchover malfunction will be to replace the power circuit board for all affected LTV Series Ventilators.

Customers are instructed to follow the Interim Instructions described in Pulmonetic Systems' November 1, 2004 , and December 7, 2004 , recall notifications.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

 

For additional information on this product recall, see the Pulmonetics Systems December 7, 2004, Interim Instructions and the December press release.

Also, for additional information on this product recall, see the FDA Enforcement Report