Physio Control, Inc.: Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

Recall number

Z-1906-2008

Recalling firm

Physio Control, Inc.

Product

Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

Status

Terminated

Initiated

2008-04-16

Posted

2008-09-16

Terminated

2011-03-29

Reason

The LIFEPAK 20e defibrillator / monitors with software versions 058 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shock or no shock decision. When Auto Analyze is set to On in AED mode the device initiates the SAS analysis immediately (no waiting period or warning prior to anal

Root cause

Software design

Action

On April 16, 2008, a letter was sent to the firms customers, via certified mail explaining the recall, giving product and software version information, request for customer to forward the notification to all sites and recommending the following: "Keep the defibrillator in service... Check the Auto Analyze Setup Option for each of your devices. If Auto Analyze is set to ON, change the setting to one of the other two choices: OFF or After First Shock... Follow the enclosed instructions to confirm or change the Auto Analyze Setup Option setting...If you update your defibrillator with new software, confirm the Auto Analyze Setup Option is set to OFF or After First Shock". Instructions for changing the auto analyze setup option for the LP 12 and LP20 were attached to the letter. There was no software issued in response to this action. Since LP20 customers may purchase a software program allowing them to update their defibrillator software, the letter recommends confirming Auto Analyze Setup Option is set to OFF or After First Shock if new software is installed . The default setting for the software update is Auto-Analyze ON. Contact Technical Support at 1-800-442-1142, option 5 - 6:00 a.m. to 4:00 p,m, (Pacific), Monday - Friday or visit www.Physio-Control-notices.com/sas if you have questions.

Quantity

969 units

Distribution

Product distributed nationwide and includes: 2 distributors, 157 direct accounts, 2,069 hospitals, 51 Department of Defense accounts, 58 miscellaneous government accounts, 3,295 first responders, 43 international accounts. International accounts are located in the following countries: ARGENTINA, AUSTRALIA, BARBADOS, BOLIVIA, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, COSTA RICA, DOMINICAN REPUBLIC, GERMANY, GUAM, GUATEMALA, GUYANA, HONG KONG, JAMAICA, JAPAN, MEXICO, NETHERLANDS ANTILLES, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PARAGUAY, PERU, PUERTO RICO, TRINIDAD, UNITED STATES, URUGUAY, and VIRGIN ISLANDS.

Lot, serial or model codes

LP20e Part Number: 3202487-104, 3202487-105, 3202488-053, 3202488-054; LP20e SN: 35664917, 35664919, 35664920, 35664921, 35664923, 35664924, 35664925, 35664926, 35664927, 35664928, 35664929, 35664931, 35664932, 35664933, 35664934, 35664936, 35664937, 35664938, 35664939, 35664941, 35664942, 35664943, 35664944, 35664945, 35664946, 35664947, 35664948, 35664949, 35664951, 35664952, 35664953, 35664954, 35664955, 35664956, 35664957, 35664958, 35664960, 35664961, 35664962, 35664963, 35664964, 35664965, 35664966, 35664968, 35664969, 35664970, 35664971, 35664973, 35664974, 35664975, 35664976, 35664977, 35664979, 35664981, 35664982, 35664983, 35664985, 35664986, 35664987, 35811291, 35811292, 35811293, 35811294, 35811295, 35811296, 35811298, 35811299, 35811300, 35811301, 35811302, 35811303, 35811304, 35811305, 35811306, 35811307, 35811308, 35811309, 35811310, 35811311, 35811312, 35811313, 35811315, 35811316, 35811317, 35811318, 35811319, 35811320, 35811321, 35811322, 35811323, 35811324, 35811325, 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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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