Cardiac Science Corporation
Medical device manufacturer in Deerfield, WI.
21510(k) clearances
0PMA approvals
40recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K143714 | Powerheart G5 AEDMKJ · Traditional | 05/04/2015SE |
| K122758 | Powerheart G5 AEDMKJ · Traditional | 02/12/2014SE |
| K113176 | Mysense HeartDSH · Traditional | 12/21/2011SE |
| K102496 | Powerheart AED G3 Semi-Automatic, Powerheart AED G3 Automatic, Powerheart AED G3 Pro…MKJ · Special | 06/09/2011SE |
| K093211 | Carecenter MDDPS · Traditional | 06/03/2010SE |
| K091943 | Powerheart AED G3, Model 9390E, Powerheart AED G3 Automatic, Model 9390AMKJ · Special | 09/10/2009SE |
| K082090 | 9131 Defibrillation ElectrodesMKJ · Special | 12/12/2008SE |
| K082173 | Q-Stress and Heartstride, Models QSTRESS/Q40 and H4/H4SDPS · Special | 08/26/2008SE |
| K060934 | Modification to Powerheart EcdMKJ · Special | 05/15/2006SE |
| K060167 | Atria 3100, Atria 6100DPS · Abbreviated | 04/19/2006SE |
| K052316 | Powerheart EcdMKJ · Traditional | 01/03/2006SE |
| K052161 | Powerheart AED G3 (Model 9390E), Powerheart AED G3 Automatic (Model 9390A)MKJ · Special | 10/21/2005SE |
| K040637 | Powerheart AED G3 ProMKJ · Traditional | 08/06/2004SE |
| K040438 | Powerheart AED G3AMKJ · Traditional | 07/01/2004SE |
| K031987 | Powerheart AED G3, Model 9300MKJ · Special | 07/30/2003SE |
| K022929 | Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart AED, Model…MKJ · Traditional | 01/27/2003SE |
| K022210 | Multifunctional Electrode Models 9640, 9650MKJ · Traditional | 10/04/2002SE |
| K012197 | Powerheart Cardiac Rhythm ModuleMKJ · Traditional | 11/16/2001SE |
| K993533 | Powerheart AecdMKJ · Special | 01/24/2000ST |
| K982710 | Aecd Arrhythmia Detection SoftwareMKJ · Special | 08/10/1998ST |
| K970741 | Powerheart AecdMKJ · Traditional | 10/16/1997SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1938-2019 Class II | Powerheart G5 Automatic AEDSub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the… | 06/04/2019Terminated |
| Z-0829-2016 Class II | 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A…Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too high, the… | 01/14/2016Terminated |
| Z-1057-2012 | Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following…The affected Automated External Defibrillators (AEDs) contains a circuit board manufactured with a component… | 01/13/2012Terminated |
| Z-3265-2011 | Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency…Cardiac Science Corporation (CSC) has identified two errors, 0x48 and 0x99, that have repeatedly occurred… | 06/30/2011Terminated |
| Z-2917-2011 | Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN…Cardiac Science Corporation (CSC) intent to end service support and discontinue accessory sales of… | 06/29/2011Terminated |
| Z-0589-2011 | GE Responder 2000 Defibrillator/Monitor, models 2025653, 2026109, and 2026114 that were…Some units may be non-operational during a rescue, due to a defective PCB interconnect on traces connected… | 04/28/2010Terminated |
| Z-1249-2010 | Cardiovive 92532 automated external defibrillator. This semi-automatic model requires…A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver… | 02/03/2010Terminated |
| Z-1248-2010 | Responder 2023440 automated external defibrillator. This semi-automatic model requires…A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver… | 02/03/2010Terminated |
| Z-1247-2010 | Powerheart 9390E automated external defibrillator. This semi-automatic model requires…A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver… | 02/03/2010Terminated |
| Z-1246-2010 | Powerheart 9390A automated external defibrillator. This fully automatic model does not…A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver… | 02/03/2010Terminated |
| Z-1245-2010 | Powerheart 9300P automated external defibrillator. This semi-automatic model requires…A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver… | 02/03/2010Terminated |
| Z-1244-2010 | Powerheart 9300E automated external defibrillator. This semi-automatic model requires…A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver… | 02/03/2010Terminated |
| Z-1243-2010 | Powerheart 9300A automated external defibrillator. This fully automatic model does not…A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver… | 02/03/2010Terminated |
| Z-1810-2010 | Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic…The K302 relay switch of the G3 series AED product line may experience an early failure. If the K302… | 12/18/2009Terminated |
| Z-0778-2010 | NK 9200G. CardioLife automated external defibrillator. This semi-automatic model…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0777-2010 | NK 9231 CardioLife automated external defibrillator. This semi-automatic model requires…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0776-2010 | GE Responder 2023440 automated external defibrillator. This semi-automatic model…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0775-2010 | GE Responder 2019198 automated external defibrillator. This semi-automatic model…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0774-2010 | Burdick Cardiovive 92533 automated external defibrillator. This semi-automatic model…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0773-2010 | Burdick Cardiovive 92532 automated external defibrillator. This semi-automatic model…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0772-2010 | Burdick Cardiovive 92531 automated external defibrillator. This semi-automatic model…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0771-2010 | Cardiac Science Powerheart 9390E automated external defibrillator. This semi-automatic…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0770-2010 | Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0769-2010 | Cardiac Science Powerheart 9300P automated external defibrillator. This semi-automatic…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0768-2010 | Cardiac Science Powerheart 9300E automated external defibrillator. This semi-automatic…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0767-2010 | Cardiac Science Powerheart 9300D automated external defibrillator. This semi-automatic…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0766-2010 | Cardiac Science Powerheart 9300C automated external defibrillator. This semi-automatic…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0765-2010 | Cardiac Science Powerheart 9300A automated external defibrillator. This fully automatic…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-1683-2010 | Responder 2000 Defibrillator/Monitor Models: 2025653, 2026109, and 2026114. Intended…The Operators Manual may not have adequate information to clearly explain some device behaviors. Pressing… | 10/15/2009Terminated |
| Z-1424-2010 | Cardiac Science, Automated External Defibrillator (AED) under the following brand names…Certain models of Powerheart G3 AEDs may not have received adequate electrical safety testing prior to being… | 10/12/2009Terminated |
| Z-1757-2010 | Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac…28 stress and rehab treadmills manufactured between September 2006 and January 2009 may not have received… | 03/30/2009Terminated |
| Z-0922-2009 | GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by…Potential for AED to not deliver defibrillation therapy. | 10/13/2008Terminated |
| Z-0921-2009 | Cardio Vive 92532 AED, BURDICK Manufactured by Cardiac Science Corporation, Automated…Potential for AED to not deliver defibrillation therapy. | 10/13/2008Terminated |
| Z-0920-2009 | Cardiac Science Powerheart Automated External Defibrillator G3 9390EPotential for AED to not deliver defibrillation therapy. | 10/13/2008Terminated |
| Z-0919-2009 | Cardiac Science Powerheart Automated External Defibrillator G3 9390APotential for AED to not deliver defibrillation therapy. | 10/13/2008Terminated |
| Z-0918-2009 | Cardiac Science Powerheart Automated External Defibrillator G3 9300E.Potential for AED to not deliver defibrillation therapy. | 10/13/2008Terminated |
| Z-0917-2009 | Cardiac Science First Save Automated External Defibrillator G3 9300CPotential for AED to not deliver defibrillation therapy. | 10/13/2008Terminated |
| Z-0916-2009 | Cardiac Science Powerheart Automated External Defibrillator G3 9300APotential for AED to not deliver defibrillation therapy. | 10/13/2008Terminated |
| Z-1714-2008 | Electrode Adaptor Cable Quick-Combo System, Model 9055 The 9055 Electrode Adaptor is…Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is… | 01/23/2008Terminated |
| Z-1616-2008 | 9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System…Adaptor Cable Incorrectly Manufactured: The red and white connector ends of the adapter are switched.… | 01/23/2008Terminated |