U.S. Food and Drug Administration - CDRH Mobile
Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule

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
 June 3, 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.
17400 Medina Road, Suite 100
Minneapolis, MN 55447
Reason for Recall:
 Device may malfunction due to a capacitor in the device which may shift
Recall: over time preventing the audible alarm from sounding if the ventilator stops operating.
Public Contact:
 Mr. Darryl Shelby
Regulatory Affairs Specialist
Phone: 763-398-8300
FDA District:
 Los Angeles District
FDA Comment:
 FDA considers there to be high risk of adverse health consequences from continued use of this device until the correction is made.
  For additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2002/ENF00752.html Scroll down to “Recalls and Field Corrections: Device – Class 1

Updated September 3, 2002

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH