Atlas FDA

Esprit Ventilator.

FDA device recall Z-0722-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm
Respironics California Inc
Reason for recall
Valves may stick in the closed position due to manufacturing error.
Action taken
Uninstalled ventilators were returned for change of the inhalation module. Otherwise, service technicians replaced the module in the field. Recall is complete.
Root cause
Other
Status
Terminated
Product code
CBK
Quantity affected
20
Distribution
OH, NY, NJ, PA, CO, IL, MI, NC, GA. England.
Date initiated
2003-07-14
Date posted
2004-07-20
Date terminated
2004-03-17
Location
Carlsbad, CA

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