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U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK20 and LIFEPAK20e Defibrillator

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 Class 2 Device Recall LIFEPAK20 and LIFEPAK20e Defibrillatorsee related information
Date Initiated by FirmMay 13, 2008
Date PostedSeptember 08, 2008
Recall Status1 Terminated 3 on March 20, 2011
Recall NumberZ-2011-2008
Recall Event ID 48139
510(K)NumberK063119 
Product Classification External Defibrillator - Product Code LDD
ProductKeypad replacement for LIFEPAK20 or LIFEPAK20e. This product is an external defibrillator.
Code Information Keypad lot codes (Lot codes appear on the original product packaging, but are not stamped onto the keypads): 10-07, 11-07, 12-07-P093, 12-07-P094, 01-08-N116, 01-08-N126, 01-08-P091, 01-08-P093. Customers who received the effected keypad will not be able to identify the unit based on lot code unless they retained the original product labeling.
FEI Number 3015876
Recalling Firm/
Manufacturer		 Physio Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information ContactTodd Bandy
425-867-4000 Ext. 4644
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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 in Commerce78 keypads
DistributionProduct 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = LDD
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