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.
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