Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0445-05

Model 740 and 760 series Ventilators

Medtronic, Inc. / initiated 2004-12-17 / Terminated

Nellcor Puritan Bennett Inc began a recall of Model 740 and 760 series Ventilators on . The reason FDA records is "Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0445-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic, Inc.
Product
Model 740 and 760 series Ventilators.
Product code
CBK Ventilator, Continuous, Facility Use
Reason for recall
Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss.
FDA root cause
Other
Action
Customers 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.
Quantity in commerce
13,010 worldwide, 3,948 in USA and territories.
Distribution
Worldwide.
Product codes and lots
All units ever manufactured. The product may be identified and tracked through serial numbers. This is a tracked device.