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U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK

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  Class 2 Device Recall LIFEPAK see related information
Date Initiated by Firm November 12, 2003
Date Posted January 06, 2004
Recall Status1 Terminated 3 on February 25, 2004
Recall Number Z-0294-04
Recall Event ID 27864
510(K)Number K012274  
Product Classification unknown device name - Product Code MKI
Product LIFEPAK 20 defibrillator/monitor. Paddle sets, an optional accessory item, used with the LP 20.
Code Information 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
Recalling Firm/
Manufacturer		 Medtronic Physio Control Corp
11811 Willows Rd NE
Redmond WA 98073
For Additional Information Contact
425-867-4000
Manufacturer Reason
for Recall		 Device unable to recognize the connection to the hard paddles accessory.
FDA Determined
Cause 2		 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 in Commerce 180 sets
Distribution The firm distributed devices to 32 hospitals and medical centers located throughout the United States.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKI and Original Applicant = MEDTRONIC PHYSIO-CONTROL CORP.
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