Recall Z-2010-2008 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Physio Control, Inc.
Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillator sold internationally only
| Date | Sep 8, 2008 (initiated May 13, 2008) |
| Status | Terminated |
| Reason | A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the "MANUAL" button located on the lower left corner of the door. This may lead to a delay in defibrillation therapy. |
| Root cause | Device Design |
| Action | On 5/13/08, the firm sent out letters to their domestic customers via Certified Receipt. The letter advised customers of the recall and instructed them to do the following, "Keep the defibrillator in service. If pressing the MANUAL button does not take the defibrillator out of AED mode, press one of the following keys to select manual mode: "ENERGY SELECT", "CHARGE", "PACER", OR "LEAD"... Please call your local Physio-Control service representative to arrange a service visit to replace the keypads." If you have questions, contact Technical Support at 1-800-442-1142, option 5. |
| Quantity | 24 units |
| Distribution | Product distributed to 1 US embassy, 97 domestic medical facilities nationwide, and 5 foreign consignees including the following countries: Germany, Netherlands, Canada, Australia and Hong Kong. |
| 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 |