Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillator sold internationally only
FDA Recall Z-2010-2008 · Posted 2008-09-08
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Recalling FirmPhysio Control, Inc.
Recall StatusTerminated
Product CodeLDD
Date Initiated2008-05-13
Date Terminated2011-03-20
Product Quantity24 units
Reason for Recall
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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