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U.S. Department of Health and Human Services

Safety

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Pulmonetic Systems LTV Series of Ventilators, Universal Cable Adaptor

Audience: Users of the Pulmonetic Systems LTV Series of Ventilators

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. 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.

[December 9, 2004 - Recall Notice - FDA]