Recall Z-0925-2007 ยท MJK Dna Probe, Trichomonas Vaginalis
Medtronic Emergency Response Systems, Inc.
LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics.
| Date | Jun 9, 2007 (initiated Apr 27, 2007) |
| Status | Terminated |
| Reason | White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment. |
| Root cause | Other |
| Action | On 04/27/2007 firm sent letters via return receipt to all domestic and foreign customers. The letter recommends for customers to turn the defibrillator power off and back on to restore normal operation in the event of a white screen condition. In addition, the letter advises that a representative from the firm will contact customer to make arrangements to provide a software upgrade to correct the issue. |
| Quantity | 859 units |
| Distribution | Distribution is Worldwide. Devices are used by healthcare providers in hospital or healthcare clinic settings. |
| 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 |