Recall Z-1502-06 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Medtronic Emergency Response Systems, Inc.
LIFEPAK 20 external defibrillator/monitor
| Date | Sep 13, 2006 (initiated Aug 30, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 2,831 worldwide |
| Distribution | Units were distributed worldwide to hospitals and medical centers. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012274 | MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER Medtronic Physio-Control Corp., Feb 5, 2002 |