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U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK 15 MONITOR/DEFIBRILLATOR

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  Class 2 Device Recall LIFEPAK 15 MONITOR/DEFIBRILLATOR see related information
Date Initiated by Firm August 12, 2009
Date Posted September 18, 2009
Recall Status1 Terminated 3 on August 10, 2012
Recall Number Z-2110-2009
Recall Event ID 53087
510(K)Number K082937  
Product Classification Automated external defibrillators (non-wearable) - Product Code DXN
Product Biphasic LIFEPAK 15 Monitor/Defibrillator.

The LIFEPAK 15 is a battery operated monitor with an external portable defibrillator used by healthcare providers in EMS, hospital and clinic settings. It operates in a manual or semi-automatic defibrillation mode and is offered with optional monitoring functions including Non-Invasive Blood Pressure (NIBP). When clinically indicated the LIFEPAK 15 allows the operator to deliver a brief, high energy, external shock through the chest to a patient's heart.
Code Information Serial numbers are various and non-contiguous:  Domestic Device SN, 37937856, 37937866, 37963295, 37963300, 37963302, 37963322, 37963323, 37963328, 37924152, 37968424, 37968429, 37968715, 37968716, 37968717, 37968718, 37968721, 37968722, 37968724, 37923203, 37923213, 37964622, 37976542, 37976544, 37976545, 37976551, 37923162, 37923205, 37923208, 37923100, 37870245, 37924157, 37937888, 37923079, 37923153, 37923078, 37924153, 37963927, 37964561, 37928794, 37933262, 37930942, 37930944, 37930946, 37930964, 37930966, 37930977, 37930986, 37930988, 37930989, 37930990, 37930993, 37933240, 37933241, 37933244, 37937843, 37937846, 37937847, 37937848, 37937849, 37937850, 37937854, 37937855, 37937862, 37937870, 37937871, 37937873, 37937885, 37937886, 37937887, 37937891, 37937892, 37963929, 37964567, 37964592, 37963324, 37964615, 37964559, 37964585, 37964610, 37963935, 37968422, 37963932, 37964557, 37964569, 37964628, 37963931, 37964621, 37964630, 37968425, 37933257, 37963928, 37963325, 37963930, 37964591, 37964596, 37964587, 37964554, 37964609, 37964560, 37963926, 37964564, 37964626, 37964618, 37964600, 37964601, 37964607, 37963329, 37964594, 37963923, 37963327, 37963292, 37964613, 37964608, 37964575, 37964589, 37964623, 37964565, 37964588, 37964617, 37964599, 37964614, 37968427, 37928964, 37933267, 37930962, 37930968, 37930987, 37931003, 37933246, 37933249, 37933250, 37937842, 37937852, 37937864, 37937865, 37937867, 37937872, 37937874, 37937881, 37937883, 37937889, 37937890, 37937894, 37937896, 37964552, 37937851

International Consignees Device SN, 37937845, 37937869, 37937884, 37937893, 37937895, 37963250, 37968304, 37445046, 37799902, 37799911, 37799913, 37799914, 37799915, 37800767, 37800768, 37800769, 37800771, 37803641, 37803642, 37803643, 37803644, 37803645, 37803646, 37803647, 37803648, 37803650, 37803651, 37804604, 37804605, 37804606, 37804607, 37804615, 37805136, 37805137, 37805138, 37805139, 37805140, 37805141, 37805142, 37805143, 37805144, 37805145, 37805146, 37805147, 37805148, 37805149, 37805150, 37805151, 37805152, 37805153, 37805154, 37805155, 37805156, 37805157, 37805158, 37805159, 37805160, 37805161, 37805162, 37805163, 37805164, 37805165, 37805166, 37805167, 37805168, 37805169, 37805170, 37805171, 37805172, 37805173, 37805174, 37805182, 37805183, 37805184, 37805185, 37805186, 37805187, 37805188, 37805189, 37805190, 37805191, 37805192, 37805193, 37805194, 37805195, 37805196, 37805197, 37805198, 37805199, 37805200, 37805201, 37805202, 37808586, 37808587, 37808588, 37808589, 37808590, 37808591, 37808592, 37808593, 37808594, 37808595, 37808596, 37808597, 37808598, 37808599, 37808600, 37810775, 37810776, 37810777, 37810778, 37810779, 37810780, 37810781, 37810782, 37810783, 37810784, 37810785, 37810786, 37810787, 37810788, 37810789, 37810819, 37810820, 37810821, 37810823, 37869808, 37869810, 37869811, 37869812, 37869814, 37869816, 37869817, 37869818, 37869820, 37869821, 37869822, 37869823, 37869824, 37869827, 37869828, 37869829, 37870210, 37870211, 37870213, 37870214, 37870215, 37870216, 37870217, 37870218, 37870219, 37870220, 37870221, 37870222, 37870223, 37870224, 37870225, 37870226, 37870228, 37870229, 37870236, 37870246, 37870247, 37870249, 37870250, 37870251, 37870252, 37870254, 37870255, 37870256, 37870258, 37870259, 37870260, 37900520, 37900602, 37900603, 37900604, 37900605, 37900607, 37900608, 37900610, 37900611, 37900612, 37900615, 37900616, 37900617, 37900618, 37900621, 37900622, 37900623, 37900624, 37900625, 37900626, 37900628, 37900629, 37900630, 37900631, 37900632, 37900633, 37923087, 37923112, 37923125, 37923155, 37923156, 37923201, 37923202, 37923204, 37923206, 37923210, 37923211, 37923214, 37924154, 37924156, 37924160, 37924163, 37924165, 37928454, 37928456, 37928457, 37928458, 37928459, 37928460, 37928461, 37928462, 37928463, 37928790, 37928791, 37928792, 37928793, 37928958, 37928967, 37933252, 37933253, 37933254, 37933259, 37933260, 37933261, 37933263, 37933264, 37933265, 37933266, 37933268, 37933269, 37933270, 37928968, 37930948, 37930960, 37930970, 37930976, 37930983, 37930984, 37930991, 37930994, 37930995, 37930997, 37930999, 37931000, 37931001, 37931005, 37933237, 37933238, 37933242, 37933245, 37933247, 37933248, 37933275, 37933276, 37933277, 37933280, 37937844, 37963303, 37968306, 37869809, 37869815, 37869825, 37869826, 37870212, 37923207, 37924155, 37924164, 37928455, 37928960, 37928961, 37933256, 37930940, 37930953, 37930972, 37930974, 37930979, 37930982, 37930992, 37930996, 37931004, 37933243, 37933251, 37933271, 37933273, 37933278, and 37933279.  
Recalling Firm/
Manufacturer		 Physio Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information Contact
425-867-4000
Manufacturer Reason
for Recall		 Some LIFEPAK 15 Monitor/Defibrillators have a Non-Invasive Blood Pressure (NIBP) module that was supplied by CAS Medical Systems, Branford, Connecticut who is recalling the modules. The NIBP modules may be susceptible to sudden changes in cuff pressure. Sudden changes in cuff pressure may possibly be caused by bumping or squeezing the cuff. In some instances this may result in a screen display
FDA Determined
Cause 2		 Software design
Action The firm notified customers by letter dated August 2009. Customers will have the Noninvasive Blood Pressure (NIBP) module replaced. If additional questions about the notification, contact Technical Support by calling 1-800-442-1142, option 5, Monday-Friday 6:00 a.m. to 4:00 p.m. (Pacific Standard Time). .
Quantity in Commerce 445 devices worldwide
Distribution Worldwide Distribution -- US, AUSTRALIA, GERMANY and NETHERLANDS.
Total Product Life Cycle TPLC Device Report
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 = DXN and Original Applicant = PHYSIO-CONTROL, INC.
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