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FDA Medical Device Recalls (openFDA)

Medtronic Physio Control Corp: LIFEPAK 20 defibrillator/monitor. Paddle sets, an optional accessory item, used with the LP 20.

Recall number
Z-0294-04
Recalling firm
Medtronic Physio Control Corp
Product
LIFEPAK 20 defibrillator/monitor. Paddle sets, an optional accessory item, used with the LP 20.
Status
Terminated
Initiated
2003-11-12
Posted
2004-01-06
Terminated
2004-02-25
Reason
Device unable to recognize the connection to the hard paddles accessory.
Root cause
Other
Action
Beginning on 11/12/03 representatives from the firm visited the consignees and replaced the paddles. A letter dated November 2003 was provided to the consignees.
Quantity
180 sets
Distribution
The firm distributed devices to 32 hospitals and medical centers located throughout the United States.
Lot, serial or model codes
Part numbers: 3200936-000, 3200936-001, 3200936-003, 3200936-010.   Date codes affected: 19680, 19681, or 19682  The firm shipped sets of paddles with shipments of devices with serial numbers listed. However, a set of paddles was not shipped specifically with each LP 20, and a customer may receive (per order) more devices than paddle sets. The paddles may be used with the devices specified below, or with any other LP 20 device. LP 20 serial numbers shipped: 31481310, 31487712, 31469046, 31480240, 31488466, 31488468, 31488472, 31488479, 31488482, 31488483, 31488485, 31488486, 31488487, 31488491, 31488492, 31488494, 31488495, 31488498, 31488499, 31488500, 31488502, 31488503, 31488505, 31488970, 31488971, 31488976, 31490835, 31490862, 31490864, 31490865, 31490914, 31492668, 31494830, 31494961, 31495055, 31496204, 31496499, 31496500, 31496502, 31497170, 31497171, 31497173, 30540237, 30541490, 30524326, 31405298, 31405302, 31406327, 31406328, 31406329, 31406330, 31407066, 31420549, 31461553, 31461548, 31461559, 31461565, 31451566, 31461568, 31461569, 31461575, 31461576, 31461578, 31461580, 31461583, 31469733, 31469741, 31469747, 31481173, 31481174, 31481261, 31481265, 31481277, 31481279, 31481281, 31490863, 31490913, 31491385, 31491387, 31491390, 31491441, 31491443, 31491445, 31491384, 31491388, 31491442, 31461579, 31491444, 31494875, 31494878, 31494883, 31494884, 31490836, 31492587, 31480230, 31488975, 31494882, 31488501, 31481264, 31409217, 31481262, 31412444, 31488474, 31488470, 31481152, 31481183, 31486080, 31486083, 31488340, 31488343, 31488344, 31495057, 31495686, 31499486, 31481318, 31488973, 31491581, 31469686, 31462754, 31461567, 31461555, 31461564, 31471398, 31462757, 31461558, 31469688, 31492591, 31461574, 31480226, 31462758, 31487665, 31469037, 31469038, 31469039, 31469041, 31469043, 31469044, 31469045, 31469689, 31469690, 31480222, 31480232, 31480234, 31480238, 31469678, 31469719, 31469707, 31469727, 31461560, 31481193, 31486082, 31487666, 31461570, 31469675, 31469677, 31469680, 31469682, 31469704, 31469709, 31469714, 31481269, 31491801, 31492056, 31492128, 31469711, 31469699, 31494874, 31461551, 31493149, 31471394, 31493147, 31480235, 31461577, 31462761, 31462768, 31469670, 31481321, 31488341, 31488342, 31488481, 31488489, 31488490, 31488493, 31488497, 31488504, 31488977, 31491065, 31491580, 31491803, 31492053, 31492588, 31492589, 31492590, 31492667, 31492669, 31493144, 31493146, 31493148, 31494428, 31494430, 31494433, 31494434, 31495056, 31495058, 31495059, 31495409, 31496498, 31501828, 31501829, 31469702, 31448168, 31461573, 31469710, 31469661, 31469684, 31496197, 31481313, 31469726, 31469730, 31462762
510(k) numbers
["K012274"]
PMA numbers
not on file
Product code
MKI
Firm FEI
3015876
Firm city
Redmond
Firm state
WA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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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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