ClearanceBrief
Recall Z-0445-05 ยท CBK Ventilator, Continuous, Facility Use

Nellcor Puritan Bennett Inc

Model 740 and 760 series Ventilators.

DateJan 28, 2005 (initiated Dec 17, 2004)
StatusTerminated
ReasonCapacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss.
Root causeOther
ActionCustomers of record will be notified by letter sent FEDEX, a simple test instruction will be included to use to test the performance of the backup alarm.
Quantity13,010 worldwide, 3,948 in USA and territories.
DistributionWorldwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K964540NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM
Puritan Bennett Corp., Nov 14, 1997
K984379NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM
Puritan Bennett Corp., Dec 10, 1998