Pulmonetic Systems of Minneapolis has voluntarily recalled its LTV series of ventilators, including models 1000, 950, 900 and 800, because they can malfunction when switching from an external power source to an internal battery. This problem causes failure of the ventilator.

The recall includes all LTV series ventilators manufactured before Sept. 1, 2003, unless they are specifically marked on the back panel label of the ventilator with a music note symbol in the upper left or lower right corners. The following models and serial numbers may be affected:

LTV 1000 Serial Numbers below A06500
LTV 950 Serial Numbers below C07000
LTV 900 Serial Numbers below B03500
LTV 800 Serial Numbers below D01400

Pulmonetic sent a Safety Alert, accompanied by a Caregiver Information Sheet, to users on Sept. 7. These publications describe the malfunction and the alarms that should go off, and give detailed instructions on how to immediately correct the problem and resume ventilation. The company says it expects to provide a permanent solution for this defect by the end of October. Meanwhile, it advises that all users and caregivers read the information sheets to understand how to react should a malfunction occur.

The Food and Drug Administration calls this a Class I recall, which is the most serious type of recall and applies to situations in which there is a reasonable chance of injury or death.

To read the FDA statement, go to www.fda.gov/cdrh/recalls/recall-090804.html .

To read the press release from Pulmonetic systems, go to

www.fda.gov/cdrh/recalls/recall-090804-pressrelease.html .

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