Physio Control, Inc.: 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.

Recall number

Z-2110-2009

Recalling firm

Physio Control, Inc.

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.

Status

Terminated

Initiated

2009-08-12

Posted

2009-09-18

Terminated

2012-08-10

Reason

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

Root cause

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

445 devices worldwide

Distribution

Worldwide Distribution -- US, AUSTRALIA, GERMANY and NETHERLANDS.

Lot, serial or model codes

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.

510(k) numbers

["K082937"]

PMA numbers

not on file

Product code

DXN

Firm FEI

3015876

Firm city

Redmond

Firm state

WA

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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