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U.S. Department of Health and Human Services

Class 2 Device Recall Pulmonetic LTV Series Ventilator

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  Class 2 Device Recall Pulmonetic LTV Series Ventilator see related information
Date Initiated by Firm November 09, 2005
Date Posted November 23, 2005
Recall Status1 Terminated 3 on January 04, 2007
Recall Number Z-0184-06
Recall Event ID 33974
510(K)Number K981371  K984056  K002881  K010608  
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product 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.
Code Information A01916, A01961, A02196, A02656, A02985, A03667, A03696, A03741, A03774, A03809, A04262, A05454, A06194, A06585-A06598, A06600-A06613, A06615, A06616, A06618-A06620, A06622-A06624, A06626-A06630, A06633, A06635-A06637, A06639-A06654, A06656-A06659, A06661-A06670, A06672-A06684, A06686-A06696, A06698-A06700, A06702-A06707, A06709, A06710, A06712-A06716, A06734, A06746-A06748, A06750, A06755-A06758, A06760-A06763, A06765-A06766, A06769, A06771, A06779-A06780, A06783-A06785 and A07226.
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 2
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 151
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 and Original Applicant = PULMONETIC SYSTEMS, INC.
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