Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0984-05

LIFEPAK 20 defbrillator/monitor

Physio Control, Inc. / initiated 2005-06-17 / Terminated

Medtronic Emergency Response Systems, Inc. began a recall of LIFEPAK 20 defbrillator/monitor on . The reason FDA records is "The defibrillator may not operate if the device is turned on during an AC Loss Alert". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0984-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Physio Control, Inc.
Product
LIFEPAK 20 defbrillator/monitor
Product code
LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Reason for recall
The defibrillator may not operate if the device is turned on during an AC Loss Alert.
FDA root cause
Other
Action
On 6/17/05 the firm issued a medical device correction letter to customers advising of the problem, explained what to do if the situation occurs, and that a service representative will visit and install new software.
Quantity in commerce
3924 units
Distribution
Devices were distributed to hospitals and medical centers worldwide.
Product codes and lots
Various, noncontiguous serial numbers. Part numbers: 3202487-xxxd and 3202488-xxx.