Pulmonetic Systems, Inc. Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-1000. The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-1000 is a prescription medical device suitable for use in institutional, home and transport settings. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm.

Recommended Action

Per FDA guidance

Urgent Medical Device Recall letter dated 11/09/05 is being sent via certified mail to affected customers. The letter informs customers of the issue. A Pulmonetic Systems representative will contact the customer within 72 hours to schedule a printed circuit board replacement. Customers are advised that in the interim all ventilator-dependent patients should be constantly monitored by qualified personnel to ensure that if a malfunction occurs, alternate ventilation can be provided.

Distribution

As reported by FDA

AK, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MI, MO, NE, NV, NJ, NY, OH, OK, OR, PA, SC, TX, UT, VA, WI