Welch Allyn Protocol, Inc: Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216 (Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E)

Recall number

Z-1223-2007

Recalling firm

Welch Allyn Protocol, Inc

Product

Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216 (Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E)

Status

Terminated

Initiated

2007-08-23

Posted

2007-09-19

Terminated

2011-09-26

Reason

Failure to deliver therapy: The Welch Allyn AED20 Defibrillators may display a "Defib Comm" error message on the device display during use which may result in failure of the device to analyze the patient's ECG and deliver the appropriate therapy.

Root cause

Process control

Action

On 8/23/07 the firm sent a press release to the Associated Press for release. On 8/29/07 the firm began sending URGENT MEDICAL DEVICE RECALL letters to their consignees informing them of the possibility of the defibrillator to fail to resuscitate the patient. The accounts were asked to respond to the notification within 5 working days by faxing or mailing an enclosed response. End users will be provided with a loaner device while their unit is being serviced. Distributors were sent a separate letter request they provide their customer names to the firm so that the firm can send letters to those customers.

Quantity

1,637 devices

Distribution

Worldwide to include USA, Australia, New Zealand, South Africa, China, Hong Kong, Taiwan, Malaysia, Singapore, Phillippines, South Korea, Viet Nam, Egypt, France, Germany, Ireland, India, Israel, Pakistan, Poland, Russia, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom, Canada, Ecuador, Puerto Rico, and South America.

Lot, serial or model codes

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207211, 207212, 207213, 207214, 207215, 207216, 207217, 207218, 207219, 207220, 207221, 207222, 207223, 207224, 207225, 207226, 207227, 207228, 207229, 207230, 207231, 207232, 207233, 207234, 207235, 207237, 207238, 207239, 207240, 207241, 207242, 207243, 207244, 207245, 207246, 207247, 207248, 207249, 207250, 207251, 207252, 207253, 207254, 207255, 207256, 207257, 207258, 207259, 207260, 207261, 207262, 207263, 207264, 207265, 207266, 207267, 207268, 207270, 207271, 207272, 207273, 207274, 207275, 207276, 207277, 207278, 207279, 207280, 207282, 207283, 207284, 207285, 207286, 207287, 207288, 207289, 207290, 207291, 207292, 207293, 207294, 207295, 207296, 207297, 207298, 207299, 207300, 207301, 207302, 207303, 207304, 207305, 207306, 207307, 207308, 207309, 207310, 207311, 207312, 207313, 207314, 207315, 207316, 207317, 207318, 207319, 207320, 207321, 207322, 207323, 207324, 207325, 207326, 207327, 207328, 207329, 207330, 207331, 207332, 207333, 207334, 207335, 207336, 207337, 207338, 207339, 207340, 207341, 207342, 207343, 207344, 207345, 207346, 207347, 207348, 207349, 207350, 207351, 207352, 207353, 207354, 207355, 207356, 207357, 207358, 207359, 207360, 207361, 207362, 207363, 207364, 207365, 207366, 207367, 207368, 207369, 207370, 207371, 207372, 207373, 207374, 207375, 207376, 207377, 207378, 207379, 207380, 207381, 207382, 207383, 207384, 207387, 207389, 207390, 207391, 207392, 207393, 207394, 207395, 207396, 207397, 207398, 207399, 207400, 207401, 207402, 207403, 207404, 207405, 207406, 207407, 207408, 207409, 207410, 207411, 207412, 207413, 207414, 207415, 207416, 207417, 207418, 207419, 207420, 207421, 207422, 207423, 207424, 207425, 207426, 207427, 207428, 207429, 207430, 207431, 207432, 207433, 207434, 207435, 207436, 207437, 207438, 207439, 207440, 207442, 207443, 207444, 207445, 207445, 207446, 207447, 207448, 207449, 207450, 207451, 207452, 207453, 207454, 207455, 207456, 207457, 207458, 207459, 207460, 207461, 207462, 207463, 207464, 207465, 207467, 207468, 207469, 207470, 207472, 207473, 207474, 207475, 207476, 207477, 207478, 207479, 207481, 207484, 207485, 207486, 207487, 207492, 207495.   The following serial numbers were added: 205248, 205653, 205654, 205656, 205664, 205665, 205667, 205669, 205678, 205684, 205708, 205719, 205732, 205736, 205760, 205762, 205763, 205764, 205767, 205774, 205775, 205777, 205781, 205782, 205784, 207523, 207526, 207527, 207528, 207529, 207531, 207532, 207533, 207536, 207537, 207543, 207544, 207545, 207546, 207547, 207548, 207549, 207550, 207551, 207553, 207554, 207555, 207556, 207557, 207560, 207561, 207562, 207563, 207564, 207565, 207566, 207567, 207569, 207570, 207571, 207572, 207574, 207576, 207578, 207581, 207582, 207583, 207584, 207585, 207586, 207587, 207588, 207589, 207590, 207592, 207593, 207594, 207595, 207596, 207597, 207598, 207599, 207600, 207601, 207602, 207604, 207605, 207606, 207607, 207608, 207609, 207610, 207612, 207615, 207616, 207617, 207619, 207621, 207623, 207624, 207628, 207637, 207657, 207658, 207749, 207753, 207754, 207756, 207811, 207813, 207822, 207920, 208907, 208949, and 209240.

510(k) numbers

["K002232"]

PMA numbers

not on file

Product code

MKJ

Firm FEI

3023750

Firm city

Beaverton

Firm state

OR

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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