LIFEPAK 20 defbrillator/monitor
FDA device recall Z-0984-05 · posted 2005-07-13 · Terminated
Recall details
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Reason for recall
- The defibrillator may not operate if the device is turned on during an AC Loss Alert.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LDD
- Quantity affected
- 3924 units
- Distribution
- Devices were distributed to hospitals and medical centers worldwide.
- Date initiated
- 2005-06-17
- Date posted
- 2005-07-13
- Date terminated
- 2006-05-06
- Location
- Redmond, WA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER (K012274) | Medtronic Physio-Control Corp. | 2002-02-05 |