Z-2110-2009

Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor with an external...

Name: Z-2110-2009 Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor with an external...
Creator: Physio Control, Inc.
Published: 2009-08-12
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2009-08-12 / Terminated / root cause: software

FDA source

Physio Control, Inc. began a recall of Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor with an external portable defibrillator used by healthcare providers in... on 2009-08-12. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2110-2009
Status: Terminated
Initiated: 2009-08-12
Posted: 2009-09-18
Terminated: 2012-08-10
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.
Product code: DXN System, Measurement, Blood-Pressure, Non-Invasive
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
Root cause tag: software
FDA 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 in commerce: 445 devices worldwide
Distribution: Worldwide Distribution -- US, AUSTRALIA, GERMANY and NETHERLANDS.
Product codes and lots: 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.

Product code DXN

K082937Class IIILifepak 15 Monitor/defibrillatorPhysio-Control, Inc. / cleared 2009-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)