ClearanceBrief
Recall Z-0722-04 ยท CBK Ventilator, Continuous, Facility Use

Respironics California Inc

Esprit Ventilator.

DateJul 20, 2004 (initiated Jul 14, 2003)
StatusTerminated
ReasonValves may stick in the closed position due to manufacturing error.
Root causeOther
ActionUninstalled ventilators were returned for change of the inhalation module. Otherwise, service technicians replaced the module in the field. Recall is complete.
Quantity20
DistributionOH, NY, NJ, PA, CO, IL, MI, NC, GA. England.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.