LIFEPAK 20 external defibrillator/monitor
FDA device recall Z-1502-06 · posted 2006-09-13 · Terminated
Recall details
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Reason for recall
- Devices with v38 system software do not display a ''LOW BATTERY: CONNECT TO AC POWER'' message when the monitor is on backup (DC) battery power and may shut down without warning.
- Action taken
- On August 30, 2006 the firm issued a letter dated August 2006 and titled MEDICAL DEVICE CORRECTION. The letter advises of the issue, explains how to resume power if power is shut down without warning, and advsies that a service representative will contact the consignee to make arrangements to install new software. On 10/19/06 the firm mailed an identical letter dated October 2006 to customers for units that were later identified as being subject to the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- LDD
- Quantity affected
- 2,831 worldwide
- Distribution
- Units were distributed worldwide to hospitals and medical centers.
- Date initiated
- 2006-08-30
- Date posted
- 2006-09-13
- Date terminated
- 2011-03-25
- Location
- Redmond, WA
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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 |