Physio Control, Inc. Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillator sold internationally only Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillator sold internationally only
Brand
Physio Control, Inc.
Lot Codes / Batch Numbers
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. Device Part Number: 3202488-053, Device SN: 36053634, 36053641, 36053642, 36053647, 36053651, 36053653, 36053654, 36082047, 36082048, 36082049, 36082050, 36082051, 36082054, 36102742, 36102743, 36102744, 36102745, 36102746, 36107743, 36107744, 36107746, 36107747, 36109647, and 36109667
Products Sold
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. Device Part Number: 3202488-053; Device SN: 36053634, 36053641, 36053642, 36053647, 36053651, 36053653, 36053654, 36082047, 36082048, 36082049, 36082050, 36082051, 36082054, 36102742, 36102743, 36102744, 36102745, 36102746, 36107743, 36107744, 36107746, 36107747, 36109647, and 36109667
Physio Control, Inc. is recalling Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillator sold in due to 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 wi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026