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U.S. Department of Health and Human Services

Class 1 Device Recall LTV Series Ventilators, Models 1000, 950, 900, and 800.

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  Class 1 Device Recall LTV Series Ventilators, Models 1000, 950, 900, and 800. see related information
Date Initiated by Firm September 08, 2004
Date Posted September 28, 2004
Recall Status1 Terminated 3 on May 28, 2008
Recall Number Z-1485-04
Recall Event ID 29978
510(K)Number K981371  K984056  K002881  K010608  K032226  
Product Classification Continuous Ventilator - Product Code CBK
Product The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for use by personnel under the direction of a physician. The ventilator is suitable for use in institutional, home and transport settings.
Code Information Recalled ventilators were manufactured prior to September 2003. Models LTV 1000, 950, 900, and 900 Model contain serial numbers less than A006500, C07000, B03500, and D01400, respectively.
Recalling Firm/
Manufacturer		 Cardinal Health 203, Inc
17400 Medina Rd Ste 100
Minneapolis MN 55447-1341
For Additional Information Contact Robert C. Samec
763-398-8300
Manufacturer Reason
for Recall		 Ventilators have not consistently switched to internal battery operation when the external DC power source has become inadequate to supply stable power. This situation results in loss of ventilation to the patient.
FDA Determined
Cause 2		 Other
Action A letter titled "Important Safety Information", dated September 7, 2004, was issued to all affected customers alerting them to the possibility of ventilator failure and providing instructions for recognizing and responding to the situation.
Quantity in Commerce 10,299 ventilators
Distribution Nationwide and worldwide
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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