Physio Control, Inc.: Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external defibrillator sold internationally and domestically.

Recall number

Z-2009-2008

Recalling firm

Physio Control, Inc.

Product

Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external defibrillator sold internationally and domestically.

Status

Terminated

Initiated

2008-05-13

Posted

2008-09-08

Terminated

2011-03-20

Reason

A thicker keypad 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

1,219 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.

Lot, serial or model codes

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: 3202459-061, 3202487-015, 3202487-073, 3202487-075, 3202487-078, 3202487-079, 3202487-100, 3202488-036, 3202488-038 and 3202488-040; Device SN number: 31013593, 31018361, 31521701, 32358182, 33035378, 35506844, 35506880, 35506886, 35506887, 35512605, 35514416, 35719026, 35719588, 35719590, 35719593, 35740798, 35740799, 35742042, 35742271, 35742274, 35744129, 35744131, 35744132, 35744133, 35744201, 35744905, 35744912, 35744913, 35744914, 35744917, 35744919, 35744921, 35744931, 35744933, 35744934, 35744935, 35744939, 35744940, 35744941, 35746673, 35746683, 35746685, 36090252, 36090256, 36090257, 36090258, 36090259, 36090262, 36090264, 36090265, 36090266, 36090268, 36090269, 36090270, 36090272, 36090273, 36090274, 36090275, 36090278, 36090279, 36090280, 36090281, 36090285, 36090286, 36090287, 36090289, 36090290, 36093885, 36101738, 36101739, 36101740, 36101742, 36101743, 36101745, 36101746, 36133741, 36133760, 36137373, 36139003, 36139004, 36139008, 36139015, 36139016, 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510(k) numbers

["K063119"]

PMA numbers

not on file

Product code

LDD

Firm FEI

3015876

Firm city

Redmond

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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