Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Responder AED

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Responder AEDsee related information
Date Initiated by FirmFebruary 03, 2010
Date PostedApril 06, 2010
Recall Status1 Terminated 3 on December 08, 2011
Recall NumberZ-1248-2010
Recall Event ID 54517
510(K)NumberK031987 K040438 K040637 K052161 K091943 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductResponder 2023440 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: GE. Product name: Responder. Device Operation: Semi-automatic w/manual override. Color: GE Gold. Voice Prompt Level: Basic. CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: Yes.
Code Information SERIAL NUMBER:  4048171 
Recalling Firm/
Manufacturer		 Cardiac Science Corporation
3303 Monte Villa Pkwy
Bothell WA 98021-8969
For Additional Information ContactMichael Matysik
425-402-2206
Manufacturer Reason
for Recall		A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm began initial notification on 2/3/2010 by sending letters to all affected consignees via USPS certified mail (domestic) and FedEx (international). Also on 2/3/2010 the firm issued a global press release and posted recall information on their website. Customers are instructed to remove their affected units from service, and have been given instructions for returning their affected devices. Replacement AED(s) will be sent as they are available. For questions, please contact the firm's Cardiac Science Support at 1.888.402.2484 or. AED195@cardiacscience.com to arrange for replacement(s).
Quantity in Commerce1
DistributionDistributed to health care and emergency medical personnel and US Gov't/Military in the US and the following 44 countries: AUSTRALIA, BELGIUM, BELIZE, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, DENMARK, EGYPT, FRANCE, GERMANY, GRENADA, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TRINIDAD, AND GREAT BRITAIN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MKJ
510(K)s with Product Code = MKJ
510(K)s with Product Code = MKJ
-
-