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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Physio Control, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Physio Control, Inc. is recalling LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defi due to This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
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