Recall Z-1906-2008 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Physio Control, Inc.
Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.
| Date | Sep 16, 2008 (initiated Apr 16, 2008) |
| Status | Terminated |
| Reason | The LIFEPAK 20e defibrillator / monitors with software versions 058 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shock or no shock decision. When Auto Analyze is set to On in AED mode the device initiates the SAS analysis immediately (no waiting period or warning prior to anal |
| Root cause | Software design |
| Action | On April 16, 2008, a letter was sent to the firms customers, via certified mail explaining the recall, giving product and software version information, request for customer to forward the notification to all sites and recommending the following: "Keep the defibrillator in service... Check the Auto Analyze Setup Option for each of your devices. If Auto Analyze is set to ON, change the setting to one of the other two choices: OFF or After First Shock... Follow the enclosed instructions to confirm or change the Auto Analyze Setup Option setting...If you update your defibrillator with new softwa |
| Quantity | 969 units |
| Distribution | Product distributed nationwide and includes: 2 distributors, 157 direct accounts, 2,069 hospitals, 51 Department of Defense accounts, 58 miscellaneous government accounts, 3,295 first responders, 43 international accounts. International accounts are located in the following countries: ARGENTINA, A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063119 | LIFEPAK 20 DEFIBRILLATOR/ MONITOR Medtronic Emergency Response Systems, Inc., Dec 22, 2006 |