Z-1123-2017Class I

LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are...

Name: Z-1123-2017 LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are...
Creator: Physio-Control, Inc.
Published: 2017-01-12
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2017-01-12 / Terminated

FDA source

Physio-Control, Inc. began a recall of LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients... on 2017-01-12. FDA classified it as Class I and gives the reason as "The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1123-2017
Classification: Class I
Status: Terminated
Initiated: 2017-01-12
Posted: 2017-02-11
Terminated: 2017-09-01
Recalling firm: Physio Control, Inc.
Product: LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit Board Assembly (PCBA).
FDA root cause: Other
Action: Physio plans to send the URGENT MEDICAL DEVICE CORRECTION ACTION REQUIRED LIFEPAK 15 Monitor/Defibrillator letter, dated January 2017, to their consignees on January 12, 2017. They were informed of the problem and how to identify a malfunction during the User Test of the device as described in the chapter titled Maintaining the Equipment within the LIFEPAK 15 Operating Instructions (or follow page 2 of the notification letter). If the User Test fails, the device will illuminate the Service indicator on the device. Please contact Physio-Control immediately to schedule the device correction. This field corrective action will include replacement of the Therapy PCB assembly on all devices included in the potentially affected population. This will occur as a combination of field and depot service. Customers are required to take the following actions: 1. Please forward this letter to all of your sites, trainers and users that have an affected LIFEPAK 15 device as identified on the attached Confirmation Sheet. 2. Follow the instructions on the Confirmation Sheet for each serial number listed in your possession. Promptly return the completed Confirmation Sheet to Physio-Control. 3. If the device fails the User Test, as described above, contact Physio-Control immediately to arrange for correction of your device. 4. Continue to perform the User Test as outlined in the Daily Operators Checklist within the LIFEPAK 15 Operating Instructions. Consignees should return completed confirmation sheet to Physio: -By fax to: 1-866-448-9567 -By email to: [email protected] -Or by mail to: Physio-Control, Inc. P.O. Box 97006, Dept. 15N Redmond, WA, 98073-9706. Customers with questions call the firm at 1-800-442-1142, option 7, 6:00 A.M. to 4:00 P.M. (PST), Monday Friday.
Quantity in commerce: 338 units total (US =139 units; International = 199 units)
Distribution: Worldwide Distribution-US ( nationwide) in states of: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, VA, WA, WI, and WV and countries of: Australia, Brazil, Canada, Czech Republic, Denmark, Finland, France, French Guiana, Germany, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Qatar, Saudi Arabia, Slovenia, South Africa, Sweden, Turkey, United Arab Emirates, and United Kingdom.
Product codes and lots: SERIAL NUMBERS: 42738872, 44554102, 42701550, 42702539, 42730815, 42800549, 42803986, 42862109, 42884428, 42944609, 42989327, 43022460, 43040692, 43048791, 43066974, 43116838, 43116994, 43119477, 43132954, 43133203, 43133221, 43133906, 43154308, 43154457, 43156695, 43161425, 43163930, 43164076, 43164158, 43166133, 43206034, 43210019, 43219622, 43226291, 43230032, 43232487, 43232904, 43247389, 43251050, 43253506, 43253916, 43254032, 43258901, 43293290, 43321556, 43388132, 43388137, 43388541, 43405542, 43407947, 43409346, 43429508, 43465372, 43472036, 43472591, 43480824, 43489606, 43492883, 43576021, 43616526, 43641893, 43691775, 43715563, 43735849, 43764249, 43800357, 43805213, 43825370, 43826635, 43843347, 43869096, 43884778, 43922984, 43938506, 43947198, 43962139, 43964195, 43968233, 43981293, 43999541, 44010117, 44010465, 44039473, 44056838, 44060132, 44072885, 44073149, 44090669, 44092118, 44094122, 44108545, 44112183, 44117966, 44150897, 44167052, 44168042, 44179750, 44199424, 44225054, 44225258, 44226227, 44226585, 44226654, 44231094, 44233618, 44234803, 44234840, 44237875, 44255648, 44262283, 44262826, 44264102, 44264573, 44265421, 44271391, 44283558, 44287000, 44289115, 44293297, 44303302, 44312782, 44315479, 44327764, 44342010, 44352664, 44372343, 44416667, 44435825, 44438567, 44439898, 44449825, 44450073, 44452220, 44458445, 44460124, 44460749, 44463853, 44466514, 44473363, 44483809, 44486872, 44487784, 44487992, 44488101, 44489681, 44492189, 44492223, 44492252, 44492760, 44492832, 44494129, 44496734, 44497169, 44497196, 44497761, 44497866, 44498576, 44500827, 44500943, 44501037, 44501047, 44501112, 44501201, 44501465, 44501806, 44501832, 44502009, 44502159, 44502179, 44502310, 44502686, 44502718, 44502776, 44502815, 44502943, 44503096, 44508212, 44508273, 44508330, 44508331, 44508358, 44508440, 44508498, 44508645, 44508868, 44509074, 44509520, 44509538, 44511211, 44511231, 44511273, 44511519, 44511573, 44512604, 44513321, 44513358, 44518244, 44518479, 44518497, 44518703, 44518786, 44518917, 44518981, 44519083, 44519095, 44519255, 44519301, 44519307, 44519381, 44519548, 44524967, 44525130, 44525416, 44527324, 44530479, 44530594, 44530719, 44530800, 44531488, 44531803, 44532088, 44534804, 44534900, 44534991, 44535111, 44535241, 44535452, 44535582, 44535643, 44536176, 44536780, 44536823, 44536897, 44538798, 44538819, 44539781, 44539880, 44541779, 44541917, 44548263, 44548530, 44548558, 44548749, 44548825, 44549064, 44549220, 44549413, 44549964, 44550150, 44550234, 44550467, 44550552, 44550575, 44550613, 44550642, 44550675, 44552029, 44552066, 44552865, 44553122, 44554175, 44554259, 44554351, 44554520, 44554837, 44554941, 44555058, 44555261, 44556688, 44557824, 44558175, 44558252, 44558385, 44559077, 44559369, 44559455, 44560001, 44560185, 44561655, 44561903, 44562074, 44562559, 44562662, 44562754, 44563762, 44564474, 44564491, 44571952, 44572025, 44572171, 44572228, 44572357, 44572374, 44572595, 44572865, 44573101, 44573148, 44573485, 44573956, 44574467, 44574766, 44574771, 44574821, 44574929, 44574939, 44575793, 44575871, 44575898, 44576359, 44576647, 44577004, 44577022, 44577116, 44577219, 44578054, 44578080, 44578192, 44578272, 44579036, 44579299, 44579496, 44579697, 44579713, 44579857, 44581304, 44581382, 44583260, 44583657, 44583701, 44584213, 44586462, 44587097, 44587099, 44587181, 44587302, 44587358, 44587899, and 44587976.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1123-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1123-2017	Class I	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-10

Product code MKJ

K142430Class IIILIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. / cleared 2014-12-19

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)