What is FDA product code MKJ?

This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.

Cardiovascular › TherapeuticAutomated External Defibrillators (Non-Wearable)

M Series

Name: M Series
Brand: M Series

Defibrillator ,MAIN,MAN-2,3/5 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHSC,NELLCOR,RCD,SMR,CDMK,AC,DMST

Registry build 21.09.26

3manufacturers in China registered for this device type

219catalogue numbers in this listing

35510(k) clearances naming this product code

40recalls on this code

Who Else Makes It

All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MKJ
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24
EMI (Dongguan) Asia Limited	Dongguan	Guangdong	Contract manufacturer	9

Record

Regulatory record for M Series
Listed by	Zoll Medical Corporation, United States
FDA product code	MKJ
Device type	Automated External Defibrillators (Non-Wearable)
Device class	Class 3
Regulation	21 CFR 870.5310
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2014-09-08
Record revised	2026-02-13 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number
Storage	Handling environment temperature 0 to 55 °C; Storage environment atmospheric pressure from 0 KiloPascal; Storage environment temperature -20 to 60 °C; Storage environment humidity 5 to 95 % RH
Distribution end date	2026-01-01

Catalogue Numbers

Catalogue numbers for M Series
Catalogue number	Size	Status
40010311000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021011000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021521000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010311000003010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010511000023010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021211000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000023010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021211000023010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010011000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021511000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021311000003010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010221000023010	6.8″ x 10.3″ x 8.2″	Withdrawn
40022311100163010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010511000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000013011	6.8″ x 10.3″ x 8.2″	Withdrawn
60010011000003011	6.8″ x 10.3″ x 8.2″	Withdrawn
40010911100024010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211100003010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010010000013013	6.8″ x 10.3″ x 8.2″	Withdrawn
60010011000063011	6.8″ x 10.3″ x 8.2″	Withdrawn
60022311100163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40022211000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40022311100173010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021321000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021211000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211000103011	6.8″ x 10.3″ x 8.2″	Withdrawn
40021711000173010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021321000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000010011	6.8″ x 10.3″ x 8.2″	Withdrawn
40010111000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021011000003010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010010000013013	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000173010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021221000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010000000010013	6.8″ x 10.3″ x 8.2″	Withdrawn
60010711000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021311000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021711000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010221000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010021000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010000000070013	6.8″ x 10.3″ x 8.2″	Withdrawn
40021011000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010011000120010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010221000003010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010011000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010221000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021211000003010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010311000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021511000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021311000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010511000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021011000023010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010211000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000063011	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211100123010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021711000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211000073010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010511000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
40022711000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021311000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010011100063011	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000003010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021211110163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021211100123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021311100163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000003011	6.8″ x 10.3″ x 8.2″	Withdrawn
60010011000100010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010021000063011	6.8″ x 10.3″ x 8.2″	Withdrawn
40010311000003011	6.8″ x 10.3″ x 8.2″	Withdrawn
60010211000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021311110163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011100063011	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021511000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021521000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021211000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011100103010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010211100063011	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000100010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021711000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010911101024010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010511000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010021000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021211000003011	6.8″ x 10.3″ x 8.2″	Withdrawn
40010001100010011	6.8″ x 10.3″ x 8.2″	Withdrawn
40021221000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40022211000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021221000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010221000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000000011	6.8″ x 10.3″ x 8.2″	Withdrawn
40021511000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000123011	6.8″ x 10.3″ x 8.2″	Withdrawn
60010011000103011	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211000003011	6.8″ x 10.3″ x 8.2″	Withdrawn
40010511000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211100073010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021021000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010211000073010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010021000003010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010311000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021011000173010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211100163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010000000050013	6.8″ x 10.3″ x 8.2″	Withdrawn
40010111000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211110163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40022731100163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000103011	6.8″ x 10.3″ x 8.2″	Withdrawn
40022011000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010221000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010001000010011	6.8″ x 10.3″ x 8.2″	Withdrawn
60021311000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021211100123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40022311000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021711000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021211100103010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010000000010013	6.8″ x 10.3″ x 8.2″	Withdrawn
60010311000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010011000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010211000003011	6.8″ x 10.3″ x 8.2″	Withdrawn
40021711000073010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021211000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010311000023010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000073010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010211100073010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021211000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211000023010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010711000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021011000103011	6.8″ x 10.3″ x 8.2″	Withdrawn
60021211000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021011000103011	6.8″ x 10.3″ x 8.2″	Withdrawn
40021211110163010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021711000173010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010021000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010711000003010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021711000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010001000010011	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211000173010	6.8″ x 10.3″ x 8.2″	Withdrawn
40011211000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021021000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021311000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010221000023010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021221000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010511000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021011000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010511000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010211000103011	6.8″ x 10.3″ x 8.2″	Withdrawn
40021311000173010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010711000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010311000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021111000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010221000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010211000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021321000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021011000023010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021221000103011	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000100011	6.8″ x 10.3″ x 8.2″	Withdrawn
60010021000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010231100123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021211100163010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010211000003010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021311000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021211000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010011000013011	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211100103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211100063011	6.8″ x 10.3″ x 8.2″	Withdrawn
60010211100003010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010010000010013	6.8″ x 10.3″ x 8.2″	Withdrawn
40021011000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010311000023010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021511000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010511000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010001100010011	6.8″ x 10.3″ x 8.2″	Withdrawn
40021011000003011	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010021000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010011000003010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021011000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000120010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211000003010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010011000013010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021311100163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010211000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010921100024010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021221000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010211000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010311000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010711000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021311000063010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010011000023010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010721100103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021511000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021211000023010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010711000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010021000103011	6.8″ x 10.3″ x 8.2″	Withdrawn
60021011000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010011000010011	6.8″ x 10.3″ x 8.2″	Withdrawn
40021011000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010311000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021011000003010	6.8″ x 10.3″ x 8.2″	Withdrawn
40022011000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010020000013013	6.8″ x 10.3″ x 8.2″	Withdrawn
40010511000003010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010211000023010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021021000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010011000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
60021211100163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40022211000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40021211000123010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010911100024010	6.8″ x 10.3″ x 8.2″	Withdrawn
40022311000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010010000010013	6.8″ x 10.3″ x 8.2″	Withdrawn
60021011000163010	6.8″ x 10.3″ x 8.2″	Withdrawn
40010111000103010	6.8″ x 10.3″ x 8.2″	Withdrawn
60010711000103010	6.8″ x 10.3″ x 8.2″	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
X Series	Zoll Medical Corporation	862
E Series	Zoll Medical Corporation	571
R Series	Zoll Medical Corporation	216
Lifepak® 15 monitor/defibrillator	Physio-Control, Inc.	188
AED Plus	Zoll Medical Corporation	124
Lifepak® 12 defibrillator/monitor	Physio-Control, Inc.	122
Lifepak CR Plus and Lifepak Express defibrillators	Physio-Control, Inc.	111
M Series Biphasic	Zoll Medical Corporation	111
PadPro	ConMed Corporation	96
R&D Batteries, Inc.	R & D Batteries, Inc.	71
Lifepak® 20 and Lifepak 20e defibrillator/monitors	Physio-Control, Inc.	59
AED 3	Zoll Medical Corporation	57

Showing 12 of 312. All products under Automated External Defibrillators (Non-Wearable)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K142915	2014-12-03
K141774	2014-11-19
K133484	2014-08-01
K122839	2012-12-13
K110978	2011-05-13
K110742	2011-04-13
K110526	2011-03-25
K091561	2010-09-23
K090989	2009-09-23
K081828	2008-12-09
K080903	2008-12-04
K072430	2007-11-06
K062537	2007-02-28
K062177	2006-12-13
K060559	2006-08-17
K051475	2005-06-24
K051076	2005-05-13
K042007	2005-04-07
K041892	2005-02-04
K042417	2004-10-05
K033474	2004-05-21
K032439	2003-11-05
K011541	2002-04-11
K011388	2002-03-25
K010257	2001-02-28
K993036	2000-02-28
K991556	1999-10-21
K990762	1999-09-03
K982992	1999-03-11
K972241	1998-03-16
K942344	1995-03-13
K942850	1995-02-10
K943698	1994-12-28
K932028	1993-10-08
K932931	1993-10-07

Recalls

23 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2025-02-13	Class II	Unknown/Undetermined by firm	The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).	73 units
2025-02-13	Class II	Unknown/Undetermined by firm	The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).	960 units
2025-02-13	Class II	Unknown/Undetermined by firm	The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).	1312 units
2025-02-13	Class II	Unknown/Undetermined by firm	The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).	8,744 units
2025-02-13	Class II	Unknown/Undetermined by firm	The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).	63,607 units
2025-02-13	Class II	Unknown/Undetermined by firm	The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).	7,221 units
2025-02-13	Class II	Unknown/Undetermined by firm	The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).	56,981 units
2025-02-13	Class II	Unknown/Undetermined by firm	The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).	2268 units
2024-05-31	Class II	Use error	G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film	14885
2019-06-12	Class II	Device Design	There is a potential for the device to fail to deliver energy to the patient.	1,969
2019-06-04	Class II	Process control	Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.	5 devices	2021-11-15
2017-08-04	Class II	Process control	A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator to deliver pediatric energy levels instead of adult energy levels when used with the ZOLL R Series Defibrillator. Defective electrodes will dis	3400	2018-08-31
2016-01-14	Class II	Nonconforming Material/Component	Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too high, the AED will fail the electrode self-test and it will not be Rescue Ready, the AED STATUS INDICATOR will be RED and the AED will beep. Thi	10,943	2016-12-21
2014-09-16	Class II	Material/Component Contamination	Product sterility is not assured	237 cases (6/case)	2016-05-03
2014-09-16	Class II	Material/Component Contamination	Product sterility is not assured	41 singles	2016-05-03
2014-09-16	Class II	Material/Component Contamination	Product sterility is not assured	18 singles	2016-05-03
2014-09-16	Class II	Material/Component Contamination	Product sterility is not assured	193 cases (6/case)	2016-05-03
2014-08-26	Class II	Process control	Sterility of device is not assured	100 cases =600 units	2016-05-03
2014-08-26	Class II	Process control	Sterility of device is not assured	12 each	2016-05-03
2014-08-26	Class II	Process control	Sterility of device is not assured	198 cases	2016-05-03
2014-03-05	Class II	Software design	Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used	3,169 units	2021-01-29
2013-03-12	Class II	Nonconforming Material/Component	Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators	30 cases (300 electordes)	2015-06-17
2012-08-16	Class II	Process control	Shipped with incorrect software	11 units	2012-09-19
2012-01-13	Not classified	Process control	The affected Automated External Defibrillators (AEDs) contains a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. If the component were to fail during a rescue attempt, the AED	11,019 units (6142 units in the US and 4877 units internatio	2013-09-27
2011-06-30	Not classified	Device Design	Cardiac Science Corporation (CSC) has identified two errors, 0x48 and 0x99, that have repeatedly occurred during a device self-test in the G3 installed base over the last 6 years. These self test errors cause the device to enter into a ser	195,739 units in US	2014-02-13
2011-06-29	Not classified	Nonconforming Material/Component	Cardiac Science Corporation (CSC) intent to end service support and discontinue accessory sales of Powerheart G2 Automated External Defibrillators. Customers are recommended to choose a replacement AED prior to the current AED displaying a	48,700 units (41396 units in US; 7304 units Internationally)	2011-12-20
2011-04-21	Not classified	Software design	Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy	874 units	2014-01-23
2010-04-28	Not classified	Nonconforming Material/Component	Some units may be non-operational during a rescue, due to a defective PCB interconnect on traces connected to the reed relay. This will result in an inability to analyze the patient’s heart rhythm or deliver therapy during a rescue.	130 units	2011-12-08
2010-03-24	Not classified	Software design	Device issued Shock Advised message but failed to auto-charge the defibrillator.	1383 units	2014-01-23
2010-02-03	Not classified	Nonconforming Material/Component	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.	1	2011-12-08
2010-02-03	Not classified	Nonconforming Material/Component	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.	5104	2011-12-08
2010-02-03	Not classified	Nonconforming Material/Component	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.	1006	2011-12-08
2010-02-03	Not classified	Nonconforming Material/Component	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.	1	2011-12-08
2010-02-03	Not classified	Nonconforming Material/Component	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.	2640	2011-12-08
2010-02-03	Not classified	Nonconforming Material/Component	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.	1162	2011-12-08
2010-02-03	Not classified	Nonconforming Material/Component	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.	426	2011-12-08
2009-12-18	Not classified	Other	The K302 relay switch of the G3 series AED product line may experience an early failure. If the K302 contacts are open at the time of rescue, there is a possible delay in therapy or failure to deliver therapy.	332 units	2011-12-08
2009-11-13	Not classified	Process control	Potential for devices not to deliver therapy	45518	2014-10-24
2009-11-13	Not classified	Process control	Potential for devices not to deliver therapy	8488	2014-10-24
2009-11-13	Not classified	Process control	Potential for devices not to deliver therapy	4165	2014-10-24

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P160008	2026-05-07	HeartSines samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories	Heartsine Technologies, Ltd
P170018	2025-11-06	LIFEPAK® CR2 Automated External Defibrillator	Physio-Control, Inc.
P160032	2025-07-03	Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E	Defibtech, LLC
P210015	2025-01-29	Avive Automated External Defibrillator (AED) System	Avive Solutions Inc
P200005	2024-01-09	TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors	TZ Medical, Inc.
P200007	2023-06-23	HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads	Graphic Controls D.B.A. Vermed
P200004	2022-06-16	ConMed PadPro Multifunction Electrodes	ConMed Corporation
P160012	2021-07-08	Infant/Child Reduced Energy Defibrillation Electrodes	Physio-Control, Inc.
P160033	2021-06-14	Powerheart G5 AED	Zoll Medical Corporation
P190013	2021-02-02	AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)	AED Battery Exchange, LLC
P180028	2020-08-22	HeartStart FRx Defibrillator	Philips Medical Systems Technologies Ltd
P190007	2020-08-07	Cardinal Health Multifunctional Defibrillation Electrode	Cardinalhealth
P160022	2020-06-11	X Series and Propaq MD	Zoll Medical Corporation
P160015	2020-06-05	AED 3 Defibrillator with Uni-Padz	Zoll Medical Corporation
P160028	2020-05-11	Philips HeartStart FR3 Defibrillator	Philips Medical Systems Technologies Ltd
P160026	2020-02-13	LIFEPAK Automated External Defibrillators (AEDs)	Physio-Control, Inc.
P160034	2019-08-20	Powerheart® G3 Pro AED	Zoll Medical Corporation

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.