Events

Recall of Device Recall Powerheart AED, G2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardiac Science Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59301
  • Event Risk Class
    Class 2
  • Event Number
    Z-2917-2011
  • Event Initiated Date
    2011-06-29
  • Event Date Posted
    2011-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102212
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Reason
    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.
  • Action
    Cardiac Science Corporation (CSC) sent two "9200 SERIES CARDIAC SCIENCE AED NOTICE" letters dated August 2010 and March 2011 to all affected customers. The letters identifies the product, problem, and actions to be taken by the customers. Customers are encouraged to upgrade their devices through special offers by calling CSC at 800-426-0337, Option 2. For questions about the end of factory support for the affected devices, call the Technical Support team at 800-426-0337, Option 1. *****In August 2011, Cardiac Science sent out another updated recall notification letter to their consignees. This letter stated that once a device has entered the "Service Required" state, please contact the firm at 800.426.0337 Option 2. Per prior notifications, the 9200 series AEDs have reached the end of service life and can no longer be repaired. Information about these notifications may be found as an announcement in the Services and Support section of Cardiac Science website. Cardiac Science advised the customers to upgrade to a Powerheart AED G3 (this device supports the 2010 AHA/ERC Guidelines). It is strongly recommended that customer to choose a replacement AED prior to the current AED displaying any "Service Required" self test messages. For information about special offers to help you upgrade please call 800.426.0337. Option 2.

Device

Device Recall Powerheart AED, G2
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of AE, AT, AU, AW, BE, BR, CA, CH, CL, CN, CO, CY, CZ, DE, OK, EG, ES, FI, FR, GB, HK, HR, HU, 10, IE, IL, IN, IR, IS, IT, JP, KR, KW, KY, LB, LT, LV, MT, MX, NG, NL, NO, NZ, PE, PF, PL, PR, PT, QA, RO, RU, SA, SG, SK, SY, TH, TR, TT, TW, VG, ZA, and ZW.
  • Product Description
    Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive 92530. || The battery component is warranted for 5 years, and electrodes have a shelf life of 2 years. || The Powerheart AED G2 and CardioVive 92530 are intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province, or country regulations in which they practice.
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation
  • Manufacturer Address
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Manufacturer Parent Company (2017)
    Cardiac Science Corporation
  • Source
    USFDA