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FDA > CDRH > Medical Device Recalls > Class I Recall - Ventilator

Medical Device Recalls
Class I Recall: Ventilator

The following information relates to FDA's decision to issue a Class I recall for this product. Additional information about Class I Medical Device Recalls can be found on the CDRH Recall Page.
Date Recall
Initiated
 March 12, 2002
Product:
 Pulmonetic Systems LTV Series Ventilator, Models LTV 1000, LTV 950,
LTV 900 and LTV 800
Use:
 To provide continuous or intermittent breathing support for patients who require mechanical ventilation. Used for adult and pediatric patients weighing at least 22 pounds. Ventilator may be used in hospitals, nursing homes, home and transport settings.
Recalling Firm:
 Pulmonetic Systems, Inc.
930 South Mt. Vernon Ave.
Colton, CA 92324
Reason for Recall:
 Device may malfunction due to a damaged connector to the turbine assembly.
Recall: Malfunction causes ventilator to become inoperative. Audible and Visual alarms will alert caregiver. Backup ventilation must be provided for ventilator dependent patients.
Public Contact:
 Mr. Darryl Shelby
Regulatory Affairs Specialist
Phone: 909-783-2280 ext. 350
FDA District:
 Los Angeles District
FDA Comment:
 FDA considers there to be a life threatening risk from continued use of these ventilators until damaged connectors are replaced.
  For additional information on this product recall, see the FDA Enforcement Report locate at: http://www.fda.gov/bbs/topics/enforce/2002/ENF00746.html. Scroll down to “Recalls and Field Corrections: Device – Class 1”.

Updated September 3, 2002

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