Lifepak SLA Battery
Assy-Battery,lifepak,sla
3manufacturers in China registered for this device type
1catalogue number
18510(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.
| 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
| Listed by | Physio-Control, Inc., United States |
|---|---|
| FDA product code | MKJ |
| Device type | Automated External Defibrillators (Non-Wearable) |
| Device class | Class 3 |
| Regulation | 21 CFR 870.5310 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2014-11-10 |
| Record revised | 2023-05-03 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11141 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| X Series | Zoll Medical Corporation | 862 |
| E Series | Zoll Medical Corporation | 571 |
| M Series | Zoll Medical Corporation | 219 |
| 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 |
Showing 12 of 312. All products under Automated External Defibrillators (Non-Wearable)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142430 | 2014-12-19 |
| K130454 | 2013-08-21 |
| K122600 | 2012-10-11 |
| K103567 | 2011-03-22 |
| K102972 | 2010-12-22 |
| K082937 | 2009-03-11 |
| K073089 | 2008-07-29 |
| K991910 | 1999-09-03 |
| K983393 | 1999-05-05 |
| K973486 | 1998-01-09 |
| K962359 | 1997-11-06 |
| K955854 | 1996-11-04 |
| K953204 | 1996-01-11 |
| K941970 | 1994-12-07 |
| K925936 | 1994-06-08 |
| K892005 | 1989-06-20 |
| K892065 | 1989-06-05 |
| K853564 | 1985-10-11 |
Recalls
7 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-04-13 | Class II | Process control | Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device’s intended use may result in | 206 | |
| 2026-01-21 | Class II | Unknown/Undetermined by firm | Due to pediatric defibrillator electrode delamination | 16,499 electrodes (US/OUS: 8327/8172) | |
| 2025-07-22 | Class II | Under Investigation by firm | Due to required inspections not being performed on products/units that have gone through servicing. | 1 unit | |
| 2025-07-22 | Class II | Under Investigation by firm | Due to required inspections not being performed on products/units that have gone through servicing. | 4 units | |
| 2025-07-22 | Class II | Under Investigation by firm | Due to required inspections not being performed on products/units that have gone through servicing. | 3 units | |
| 2025-02-03 | Class II | Employee error | Incorrect keypad was incorrectly installed onto a defibrillator/monitor. | 1 | |
| 2025-01-21 | Class II | Device Design | Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system. | 622 | |
| 2024-08-30 | Class II | Vendor change control | Due to an out of tolerance tool being used on monitor/defibrillator systems. | 105 systems | |
| 2023-11-06 | Class II | Component change control | AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA. | 18,732 | |
| 2023-09-29 | Class II | Under Investigation by firm | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 1 units | |
| 2023-09-29 | Class II | Under Investigation by firm | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 4 units | |
| 2023-09-29 | Class II | Under Investigation by firm | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 8 yrs. | |
| 2023-09-29 | Class II | Under Investigation by firm | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 1 unit | |
| 2023-09-29 | Class II | Under Investigation by firm | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 5 units | |
| 2023-09-29 | Class II | Under Investigation by firm | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 2 units | |
| 2023-09-29 | Class II | Under Investigation by firm | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 8 units | |
| 2023-09-29 | Class II | Under Investigation by firm | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 1 unit | |
| 2023-09-29 | Class II | Under Investigation by firm | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 1 unit | |
| 2023-09-29 | Class II | Under Investigation by firm | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 1 unit | |
| 2022-01-13 | Class III | Process control | Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs. | 1 | 2023-05-19 |
| 2021-01-14 | Class II | Component design/selection | Due to complaints received regarding missing lid magnets which may result in premature battery depletion. | 89,763 units | |
| 2020-04-24 | Class II | Packaging change control | Packaging of infant child reduced energy electrodes was not properly sealed. | 6732 | 2023-07-27 |
| 2020-04-24 | Class II | Packaging change control | Packaging of infant child reduced energy electrodes was not properly sealed. | 118689 | 2023-07-27 |
| 2020-03-20 | Class II | Device Design | Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which | 173,459 units | 2024-01-25 |
| 2019-12-20 | Class II | Device Design | Monitor/Defibrillator may not deliver a shock after the “Shock” button on the keypad is pressed as a result of oxidation that has formed over time within the button. | 29952 | 2022-10-04 |
| 2019-12-20 | Class II | Device Design | Monitor/Defibrillator may not deliver a shock after the “Shock” button on the keypad is pressed as a result of oxidation that has formed over time within the button. | 705 | 2022-10-04 |
| 2019-02-01 | Class I | Software design | Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no respons | 13,005 units | 2024-04-18 |
| 2019-02-01 | Class I | Software design | Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no respons | 682 kits | 2024-04-18 |
| 2017-12-04 | Class I | Other | Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected p | 3831 units | 2024-04-01 |
| 2017-10-27 | Class I | Process control | The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols. | 14,219 units in total | 2019-06-12 |
| 2017-10-27 | Class I | Process control | The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols. | 14,219 units in total | 2019-06-12 |
| 2017-01-16 | Class II | Process control | The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation. | 2584 units total (1501 units in the US; 1034 units internati | 2018-09-11 |
| 2017-01-16 | Class II | Process control | The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation. | 7 units in the US and 13 modules worldwide (5 international; | 2018-09-11 |
| 2017-01-13 | Class I | Device Design | The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage. | total 133,330 units (50,046 units in the US) | 2019-08-22 |
| 2017-01-12 | Class I | Other | 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 Bo | 338 units total (US =139 units; International = 199 units) | 2017-09-01 |
| 2016-05-25 | Class II | Component change control | LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently bec | 25178 units (10,418 in US and 14,760 outside US) | 2018-09-11 |
| 2016-01-27 | Class II | Software design | The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially obscure a portion of the leading digit of the EtC02 valu | 44798 units total (23189 units in US; 21609 units internatio | 2017-03-31 |
| 2014-05-09 | Class II | Software Manufacturing/Software Deployment | Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to f | 96,611 units total (40,974 in the US and 55,637 outside the | 2018-05-29 |
| 2013-06-12 | Class II | Employee error | The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render | 139 total (125 units in the US and 14 units outside US) | 2013-09-19 |
| 2013-02-08 | Class II | Component design/selection | LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue. | 54,197 units in US and 78,627 units internationally (total 1 | 2015-11-05 |
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.
| 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.