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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 Ventilatorsee related information
Date Initiated by FirmNovember 09, 2005
Date PostedNovember 23, 2005
Recall Status1 Terminated 3 on January 04, 2007
Recall NumberZ-0185-06
Recall Event ID 33974
510(K)NumberK002881 K010608 K981371 K984056 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
ProductLap Top Ventilator (LTV) Series continuous ventilator, model LTV-950. The LTV-950 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-950 is a prescription medical device suitable for use in institutional, home and transport settings.
Code Information C01063, C01112, C01605, C02231, C02247, C02488, C03055, C03096, C03123, C03137, C03437, C03492, C03828, C03861, C03884, C04056, C04580, C05336, C06640, C07105-C07107, C07109-C07113, C07115, C07116, C07118, C07122-C07126, C07130, C07141, C07145, C07152, C07154, C07157-C07160, C07162, C07168, C07170, C07173, C07188, C07194 and C07195
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
ActionUrgent 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 Commerce51
DistributionWithin 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 CycleTPLC 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) Database510(K)s with Product Code = CBK
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