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Cardiac Science Corporation

Last updated May 30, 2026

Information

Country: US
Address: —
Website: cardiacscience.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1.262.953.3500
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 190713797

Catalogue (76)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Powerheart® Polarized Adult Defibrillation Pads	2019199-008	FDA UDI	Class III	Active
Intellisense Adult Defibrillation Pads, CPR Device, Powerheart® G5	XELAED002A	FDA UDI	Class III	Active
Powerheart® G3 Pro Rechargeable Battery	9144-101	FDA UDI	Class III	Active
Powerheart® G3 TSO Battery	9147-201-TSO	FDA UDI	Class III	Active
Intellisense™ Pediatric Defibrillation Pads Powerheart® G5	XELAED003B	FDA UDI	Class III	Active
Powerheart G5 Kit, Semi, US Eng/ESP LA	G5S-80A	FDA UDI	Class III	Active
Powerheart® AED G3 Plus Automatic AED,	9390A-1001SP	FDA UDI	Class III	Active
AED Manager, Powerheart G5	XAEDMGR01D	FDA UDI	Class III	Active
Intellisense® Battery Powerheart® G5	XBTAED001A	FDA UDI	Class III	Active
Powerheart® Adult Defibrillation Pads	9131-001	FDA UDI	Class III	Active
Powerheart® G5 Semi Automatic AED	G5S-01A	FDA UDI	Class III	Active
Responder Pro AED Battery	2023681-301	FDA UDI	Class III	Active
Powerheart® AED G3 Semi Automatic AED	9300E-1001-TSO	FDA UDI	Class III	Active
Powerheart® G5 Automatic AED	G5A-01P0	FDA UDI	Class III	Active
Powerheart® Adult Defibrillation Pads	2019199-002	FDA UDI	Class III	Active
Powerheart® G3 Battery	9142-301	FDA UDI	Class III	Active
Powerheart® AED G3 Automatic AED	9300A-01	FDA UDI	Class III	Active
Powerheart® AED G3 Automatic AED	9300A-1001-TSO	FDA UDI	Class III	Active
Powerheart® AED G3 Plus Semi Automatic	9390E-1001-TSO	FDA UDI	Class III	Active
Intellisense Adult Defibrillation Pads, Powerheart® G5	XELAED001A	FDA UDI	Class III	Active
Powerheart® AED G3 Semi-Automatic AED	9300E-01	FDA UDI	Class III	Active
Powerheart AED G3 Pro ECG Monitoring Cable	5111-001	FDA UDI	Class II	Active
Intellisense™ Pediatric Defibrillation Pads Powerheart® G5	XELAED003A	FDA UDI	Class III	Active
Powerheart® AED G3 Plus Semi Automatic	9390E-1001SP	FDA UDI	Class III	Active
AED Manager, V.2.0.5.0 Powerheart G5	XAEDMGR01C	FDA UDI	Class III	Active
Powerheart® AED G3 Plus Semi Automatic AED	9390E-1001	FDA UDI	Class III	Active
Powerheart® AED G3 Plus Automatic AED	9390A-1001-TSO	FDA UDI	Class III	Active
Powerheart® Pro Battery	9145-301	FDA UDI	Class III	Active
Powerheart® G3 Battery	9146-302	FDA UDI	Class III	Active
Powerheart® AED G3 Pro AED	9300P-1001	FDA UDI	Class III	Active
Cardiovive DM AED Battery	9143-302	FDA UDI	Class III	Active
Powerheart® AED G3 Pro AED	9300P-1101	FDA UDI	Class III	Active
Powerheart® G3 Battery	9146-301	FDA UDI	Class III	Active
Intellisense Adult Defibrillation Pads, Powerheart® G5	XELAED001B	FDA UDI	Class III	Active
Powerheart® G3 Pro Battery Charger	9044-100	FDA UDI	Class III	Active
Cardiovive AT AED Battery	9146-303	FDA UDI	Class III	Active
Powerheart® AED G3 Pro AED	9300P-1101SP	FDA UDI	Class III	Active
Powerheart® AED G3 Plus Automatic AED	9390A-01	FDA UDI	Class III	Active
Powerheart® G3 Pro Battery Charger Kit	9044-001	FDA UDI	Class III	Active
Powerheart® AED G3 Plus Automatic AED	9390A-1001	FDA UDI	Class III	Active
Powerheart® AED G3 Plus Semi-Automatic AED	9390E-01	FDA UDI	Class III	Active
Powerheart® G5 Semi Automatic AED	G5S-01P0	FDA UDI	Class III	Active
Powerheart® AED G3 Plus Automatic AED	9390A-1001-SUNY	FDA UDI	Class III	Active
Powerheart G5 Kit, Auto, US Eng/ESP LA	G5A-80A	FDA UDI	Class III	Active
Powerheart® AED G3 Pro AED	9300P-1001SP	FDA UDI	Class III	Active
Powerheart® AED G3 Pro	9300P-01	FDA UDI	Class III	Active
Powerheart® MDLink	400621-045	FDA UDI	Class III	Active
Powerheart G5 Kit, Semi, US Eng/ESP LA	G5S-80P0	FDA UDI	Class III	Active
Powerheart®Pediatric Pads	2019199-003	FDA UDI	Class III	Active
Powerheart G5 Kit, Auto, US Eng/ESP LA	G5A-80P0	FDA UDI	Class III	Active

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FDA Recalls (47)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 4, 2019	Z-1938-2019	—	terminated	Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.
Jan 13, 2012	Z-1057-2012	—	terminated	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 may not deliver defibrillation therapy.
Jun 30, 2011	Z-3265-2011	—	terminated	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 service required state. CSC remind owners/operators of the Powerheart AED devices to verify the "Rescue Readiness" of their equipment and follow maintenance pro
Jun 29, 2011	Z-2917-2011	—	terminated	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 any "Service Required" self test messages.
Apr 28, 2010	Z-0589-2011	—	terminated	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.
Feb 3, 2010	Z-1247-2010	—	terminated	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Feb 3, 2010	Z-1245-2010	—	terminated	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Feb 3, 2010	Z-1244-2010	—	terminated	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Feb 3, 2010	Z-1243-2010	—	terminated	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Feb 3, 2010	Z-1249-2010	—	terminated	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Feb 3, 2010	Z-1246-2010	—	terminated	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Feb 3, 2010	Z-1248-2010	—	terminated	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Dec 18, 2009	Z-1810-2010	—	terminated	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.
Nov 13, 2009	Z-0776-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0770-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0769-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0772-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0767-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0773-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0765-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0777-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0775-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0766-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0778-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0774-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0768-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0771-2010	—	terminated	Potential for devices not to deliver therapy
Oct 15, 2009	Z-1683-2010	—	terminated	The Operators Manual may not have adequate information to clearly explain some device behaviors. Pressing and holding down the Charge or Shock button on the Responder 2000 for more than 5 seconds causes a "Button Stuck" error. With the "Button Stuck" error, the device will automatically exit Manual mode and enter Monitor mode. The user cannot apply therapy while the device is in Monitor mode.
Oct 12, 2009	Z-1424-2010	—	terminated	Certain models of Powerheart G3 AEDs may not have received adequate electrical safety testing prior to being shipped from the factory. Affected models are: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198 and 2023440. The affected devices were manufactured between October 29, 2003 and February 10, 2009.
Mar 30, 2009	Z-1757-2010	—	terminated	28 stress and rehab treadmills manufactured between September 2006 and January 2009 may not have received adequate electrical safety testing prior to being shipped from the factory. If these components break down in the field, a patient or operator could be exposed to excess touch currents on the surface of the product. Because safety testing may not have allowed for complete evaluation of the el
Oct 13, 2008	Z-0921-2009	—	terminated	Potential for AED to not deliver defibrillation therapy.
Oct 13, 2008	Z-0917-2009	—	terminated	Potential for AED to not deliver defibrillation therapy.
Oct 13, 2008	Z-0918-2009	—	terminated	Potential for AED to not deliver defibrillation therapy.
Oct 13, 2008	Z-0920-2009	—	terminated	Potential for AED to not deliver defibrillation therapy.
Oct 13, 2008	Z-0916-2009	—	terminated	Potential for AED to not deliver defibrillation therapy.
Oct 13, 2008	Z-0919-2009	—	terminated	Potential for AED to not deliver defibrillation therapy.
Oct 13, 2008	Z-0922-2009	—	terminated	Potential for AED to not deliver defibrillation therapy.
Jan 23, 2008	Z-1714-2008	—	terminated	Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used.
Jan 23, 2008	Z-1616-2008	—	terminated	Adaptor Cable Incorrectly Manufactured: The red and white connector ends of the adapter are switched. Therefore, the cable will not connect to the electrodes as indicated in the instructions.
Jan 27, 2006	Z-0623-06	—	terminated	Some Powerheart AED Model 9300A may contain a suspect electronic component and there is a remote likelihood that the function of this device may be interrupted during the charge.
Nov 12, 2004	Z-0400-05	—	terminated	AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.
Nov 12, 2004	Z-0399-05	—	terminated	AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.
Nov 12, 2004	Z-0398-05	—	terminated	AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.
May 24, 2004	Z-1034-04	—	terminated	Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on.
May 24, 2004	Z-1033-04	—	terminated	Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on.
May 4, 2004	Z-0990-04	—	terminated	Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work.
May 4, 2004	Z-0991-04	—	terminated	Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work.