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U.S. Department of Health and Human Services

Medical Devices

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Pulmonetic Systems LTV Series Ventilator, Models LTV 1000, LTV 950, LTV 900 and LTV 800:

Class I Recall
Date Recall
Initiated:
June 3, 2002
Product:
Pulmonetic Systems LTV Series Ventilator, Models LTV 1000, LTV 950,
LTV 900 and LTV 800
Use:
To provide continuous or intermittent breathing support for patients who require mechanical ventilation. Used for adult and pediatric patients weighing at least 22 pounds. Ventilator may be used in hospitals, nursing homes, home and transport settings.
Recalling Firm:
Pulmonetic Systems, Inc.
17400 Medina Road, Suite 100
Minneapolis, MN 55447
Reason for Recall:
Device may malfunction due to a capacitor in the device which may shift
Recall: over time preventing the audible alarm from sounding if the ventilator stops operating.
Public Contact:
Mr. Darryl Shelby
Regulatory Affairs Specialist
Phone: 763-398-8300
FDA District:
Los Angeles District
FDA Comment:
FDA considers there to be high risk of adverse health consequences from continued use of this device until the correction is made.