Class 2 Device Recall Pulmonetic LTV Series Ventilator

• Date Initiated by Firm: November 09, 2005
• Date Posted: November 23, 2005
• Recall Status: Terminated on January 04, 2007
• Recall Number: Z-0186-06
• Recall Event ID: 33974
• 510(K)Number: K002881 K010608 K981371 K984056
• Product Classification: Ventilator, Continuous, Facility Use - Product Code CBK
• Product: Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-900. The LTV-900 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-900 is a prescription medical device suitable for use in institutional, home and transport settings.
• Code Information: B01117, B01236, B01483, B01637, B01640, B01655, B01802, B01816, B01954, B01974, B01997, B03500-B03524, B03526-B03536
• Recalling Firm/ Manufacturer: Pulmonetic Systems, Inc.; 17400 Medina Rd Ste 100; Minneapolis MN 55447-1341
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 47
• Distribution: Within the US to AK, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MI, MO, NE, NJ, NY, NV, OH, OK, OR, PA, SC, TX, UT, VA and WI. OUS to include: Belgium, Brazil, Canada, India, Italy, Korea and United Kingdom
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CBK