Physio Control, Inc.: LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator (PAD). It is a small lightweight device intended for use by minimally trained responders to treat victims of sudden cardiac arrest... Product is capable of 30 full discharges. Labeling on the device states LIFEPAK CR Plus LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA.

Recall number

Z-2341-2008

Recalling firm

Physio Control, Inc.

Product

LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator (PAD). It is a small lightweight device intended for use by minimally trained responders to treat victims of sudden cardiac arrest... Product is capable of 30 full discharges. Labeling on the device states LIFEPAK CR Plus LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA.

Status

Terminated

Initiated

2008-08-28

Posted

2008-09-16

Terminated

2013-03-08

Reason

This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergency, the device will require that the user press the shock button instead of automatically delivering a shock as per the normal operation of the fully automatic device. Fully automatic defibrillators h

Root cause

Employee error

Action

On 8/28/08 the firm began contacting consignees by telephone and stating that the LIFEPAK CR Plus defibrillators were discomfiture as semi-automatic, and that a responder is unable to press the shock button to deliver therapy when instructed by the AED voice prompt because the shock button is covered and not visible. The consignee was instructed that the unit(s) would be replaced immediately. This phone contact was followed by a letter flagged "'URGENT - MEDICAL DEVICE RECALL" dated August 2008 that was f axed or e-mailed the same day. The letter repeated the information provided in the telephone contact and stated to "Immediately perform one of the following actions: Remove the affected AEDs from service or Remove and discard the shock button cover (see enclosed illustration). Enclosed with the letter is an illustration providing instructions for removal of the auto shock button cover. Customer notification was completed by 9/2/08.

Quantity

249 units

Distribution

Worldwide Distribution including USA, and countries of Canada, Germany, and Hong Kong.

Lot, serial or model codes

Part number: 3200731-003, 3200731-027, and A3200731-003. Device Serial Nos:30975799, 30975800, 30976004, 30976005, 30976011, 30976016, 30976020, 30976021, 30976024, 30976025, 30976027, 30976028, 30976030, 30976031, 30976035, 30976042, 30976050, 30976051, 30976052, 30976053, 30976059, 30976060, 30976062, 30976064, 30976066, 30976067, 30976068, 30976071, 30976075, 30976080, 30976081, 30976083, 30976084, 30976087, 30976089, 30976092, 30976093, 30976094, 30976096, 30976105, 30976106, 30976107, 30976110, 30976112, 30976114, 30976122, 30976126, 30976127, 30976129, 30976132, 30976136, 30976139, 30976141, 30976142, 30976143, 30976145, 30976147, 30976148, 30976151, 30976155, 30976157, 30976160, 30976162, 30976163, 30976166, 30976169, 30976171, 30976172, 30976173, 30976177, 30976180, 30976181, 30976182, 30976194, 30976195, 30976197, 30976200, 30976205, 30976207, 30976210, 30976211, 30976216, 30976217, 30976220, 30976224, 30976232, 30976240, 30990985, 31029332, 31029333, 31029334, 31029335, 31029336, 31029337, 31029338, 31029339, 31029340, 31029341, 31029342, 31029344, 31029346, 31029347, 31029348, 31029349, 31029350, 31029351, 31029355, 31029356, 31029357, 31029358, 31029359, 31029360, 31029361, 31029362, 31029363, 31029364, 31029365, 31029367, 31029368, 31029369, 31029371, 31029373, 31029375, 31029377, 31029381, 31029387, 31029390, 31029392, 31029401, 31469750, 34574276, 34634407, 34636114, 34637837, 34637879, 34638012, 34640657, 34641247, 34645809, 34701718, 34705207, 34705216, 34709423, 34709424, 34709425, 34709428, 34709429, 34709435, 34709436, 34709437, 34709442, 34709444, 34709454, 34709459, 34709462, 34709464, 34709475, 34709495, 34709496, 34709503, 34709507, 34709510, 34709513, 34709514, 34709515, 34709525, 34709527, 34709528, 34709531, 34709532, 34709536, 34709537, 34709538, 34709540, 34709542, 34710243, 34710249, 34710256, 34710258, 34710263, 34710265, 34710268, 34710276, 34710278, 34710284, 34710304, 34710307, 34710308, 34710310, 34710311, 34710312, 34710313, 34710318, 34712073, 34712074, 34738595, 34738601, 34738606, 34738610, 34738611, 34738616, 34739021, 34739031, 34739035, 34739040, 34739050, 34739068, 34740405, 34740464, 34740555, 34740565, 34740597, 34741052, 34741073, 34741088, 34741105, 34741106, 34741301, 34741313, 34741318, 34741319, 34741332, 34741341, 34741359, 34741369, 34741373, 34741382, 34741389, 34741392, 34741393, 34741394, 34742520, 34742530, 34742531, 34742538, 34742539, 34742540, 34742542, 34742552, 34742558, 34742609, 34742612, 34742613, 34742614, 34742640, 34742649, 34742652, 34742654, and 34743762.

510(k) numbers

["K011144"]

PMA numbers

not on file

Product code

MJK

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

Copy