Lifepak CR2
Used LPCR2,WIFI,B,EN-US,ES-ES,S,2,ROS,MODET,ROS
3manufacturers in China registered for this device type
9catalogue numbers in this listing
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 |
| 510(k) | P170018 |
| Record published | 2019-01-08 |
| Record revised | 2020-05-18 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | expiry date, serial number |
| Storage | Special storage condition: ALTHOUGH DESIGNED FOR A RANGE OF -30 TO 60 C (-22 TO 140 F), STORAGE AT THESE EXTREMES IS LIMITED TO ONE WEEK. STORAGE P; Handling environment humidity 5 to 95 % RH; Storage environment humidity 5 to 95 % RH; Handling environment temperature -30 to 60 °C; Storage environment temperature 15 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 99512 | In distribution | |
| 99512 | In distribution | |
| 99512 | In distribution | |
| 99512 | In distribution | |
| 99512 | In distribution | |
| 99512 | In distribution | |
| 99512 | In distribution | |
| 99512 | In distribution | |
| 99512 | 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.