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U.S. Department of Health and Human Services

Safety

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Pulmonetic Systems LTV Series of Ventilators

Audience: Respiratory healthcare professionals and risk managers

FDA and Pulmonetic Systems, Inc. notified healthcare professionals of a Class I recall of the LTV series of ventilators, models 1000, 950, 900 and 800, designed to automatically switch to internal battery operation, allowing uninterrupted ventilation, when an external power source is removed or is no longer adequate to power the ventilator. The ventilators malfunction when switching to the internal battery, causing failure of the ventilator to breathe for the patient.

[UPDATE December 1, 2004 - Recall of Universal Cable Adaptors for medical ventilators]
[September 30, 2004 - Recall Notice - FDA]