Navigation Links
FDA Warns Users About Faulty Components in 14 External Defibrillator Models
Date:4/27/2010

ardioVive models 92531, 92532 and 92533
  • Nihon Kohden models 9200G and 9231 and
  • GE Responder models 2019198 and 2023440.

  • The FDA recommends that hospitals, nursing homes and other high-risk settings obtain alternative external defibrillators and arrange for the repair or replacement of the affected defibrillators.

    For all other users, including those who use the device at home or as part of public access programs, the FDA recommends using alternative external defibrillators if they are available, and arranging for the repair or replacement of the affected models.

    If alternative external defibrillators are not immediately available, then FDA recommends continuing to use the affected devices if needed, because they may still deliver necessary therapy.  The potential benefits of using the available external defibrillators outweigh the risk of not using any of the affected external defibrillators or the risk of device failure.

    "The FDA is issuing this notice so that users can take the proper steps necessary to assure they have access to safe and effective defibrillators," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health.

    Cardiac Science recalled its Powerheart and CardioVive models, manufactured between August 2003 and August 2009, on Nov. 13, 2009. But the FDA has since learned that additional Cardiac Science models, two marketed under the Nihon Kohden name, and two marketed by GE Healthcare as GE Responder have similar problems.

    Cardiac Science issued a software update for two of its Powerheart defibrillators in February 2010 and plans to issue si
    '/>"/>

    SOURCE U.S. Food and Drug Administration
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3

    Related medicine technology :

    1. H.E.A.T. Warns Drivers, Auto Dealers of Continuing Trend in Unconventional Auto Crimes
    2. Physicians Foundation Warns of Potential Impact From New Medicare Cuts Effective Today
    3. FDA Warns Consumers about Counterfeit Alli
    4. Toxic Chemical bisphenol A Still Not Banned By FDA; Schumer, Gillibrand Call for Ban; Govt Official Warns Public
    5. Orkin Warns of Four Pests to Avoid this Fourth of July
    6. New Federal Stem Cell Rules Would Hinder Existing Research, Consumer Group Warns
    7. Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Lebanon County Dairy
    8. Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Chester County Dairy
    9. The Results are in: Users of BodyMedias Wearable Body-Monitoring Technology Lose 3 Times More Weight
    10. Elekta VMAT Radiation Therapy Rapidly Gaining Users Worldwide as Technique Evolves
    11. Horizon Therapeutics Presents Phase 3 Study Results Identifying Risk Factors for Ulcer Development Among NSAID Users
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:3/30/2015)... Calif. , March 30, 2015  Cochlear ... has decided to leave Cochlear to join Valencia ... and friend, Jeff Greiner , who is ... Chief of Market Development and will be responsible ... of Valencia,s coin-sized neuromodulation ...
    (Date:3/30/2015)...  Edison Nation Medical, the premier healthcare innovation ... innovations to assist seniors in staying mobile and ... 8-week search will be presented to major medical ... be submitted through a secure, confidential portal at ... The objective of the Senior Mobility ...
    (Date:3/30/2015)... DURECT Corporation (Nasdaq: DRRX ) ... Phase 1 clinical trial of an oral formulation ... Regulator Program.  DUR-928 is an endogenous, small-molecule, new ... in metabolic diseases such as nonalcoholic fatty liver ... also play an important role in protecting against ...
    Breaking Medicine Technology:Cochlear VP of U.S. Sales Jerry Schloffman Accepts Chief of Market Development Position at Valencia Technologies 2Edison Nation Medical Announces Open Innovation Search Focused on Senior Mobility Products 2Edison Nation Medical Announces Open Innovation Search Focused on Senior Mobility Products 3DURECT Announces Initiation of DUR-928 Multi-Dose Phase 1 Study 2DURECT Announces Initiation of DUR-928 Multi-Dose Phase 1 Study 3DURECT Announces Initiation of DUR-928 Multi-Dose Phase 1 Study 4
    ... LAKES, N.J., Jan. 4, 2011 BD (Becton, Dickinson and Company) ... announced today that it will present at the 29th Annual J. ... p.m. (ET). A live webcast of BD,s presentation ... and will be available for replay through Monday, January 17, ...
    ... (Nasdaq: ERES ), announced today that Dr. Joel ... Company,s Chief Financial Officer, are scheduled to present at the ... on January 13, 2011 in San Francisco, California. ... corporate website at http://www.ert.com . The webcast may also ...
    Cached Medicine Technology:ERT to Present at the 29th Annual J.P. Morgan Healthcare Conference on January 13, 2011 2
    (Date:3/30/2015)... NY (PRWEB) March 31, 2015 ... / Co-Founder of Safe Hands Warm Hearts, as a ... with this prestigious distinction for leadership in home health ... the country, spanning virtually every industry and profession, the ... vibrant networking community with nearly 700,000 members and over ...
    (Date:3/30/2015)... Join local United Methodists as they Rethink ... funds to provide healthcare for the 512 students at ... place on Saturday, April 18, at 9 a.m. at ... Vaughn Road in Nashville. , Raise the Roof Academy ... reliable medical care. The nearest clinic is a three-hour ...
    (Date:3/30/2015)... CA (PRWEB) March 30, 2015 The Consumer ... Lawyer Skills for the New Attorney” seminar for attorneys who ... event brings top trial attorneys in the Southern California area ... encounter. Doctors on Liens was on hand, ... attorneys to the doctors their clients will need to help ...
    (Date:3/30/2015)... 30, 2015 GoHooper.com announces new website ... providing medical care to infants, children and adolescents and ... children. , The owner/provider Mark Hughes, MD, FAAP ... strive to provide expertise in the extensive range of ... care from health professionals who meet the medical field's ...
    (Date:3/30/2015)... 2015 Wimbledon Health Partners, the leading ... and NCV testing, is proud to ... observance of National Doctor’s Day. , “Our physicians ... but on this day, we like to publicly acknowledge ... play in healing patients, promoting overall health and making ...
    Breaking Medicine News(10 mins):Health News:National Association of Professional Women Announces Rachel L. Gregus, Manager / Co-Founder of Safe Hands Warm Hearts, a 2015 Professional Woman of the Year 2Health News:Hike2Heal and Rethink Church Raise Funds To Provide Healthcare for Ugandan Children with 3rd Annual Raise the Roof 5K on April 18 2Health News:Doctors on Liens Sponsors New Personal Injury Attorneys in Los Angeles 2Health News:Doctors on Liens Sponsors New Personal Injury Attorneys in Los Angeles 3Health News:Nashville Web Design Company Announces New Site Launch For Pediatrics Doctor 2Health News:Wimbledon Health Partners Recognizes National Doctors’ Day 2
    ... 2009 ADDY® Award for its multi-media drug education and prevention campaign and ... service announcements. , ... Los Angeles, Ca (PRWEB) March 19, 2009 -- ... 60 seconds in duration, brings home the stark reality of what substance ...
    ... replace heparin after hip- or knee-replacement surgery , ... of the experimental blood-thinning drug rivaroxaban outweigh its risks, ... Thursday. , Rivaroxaban (Xarelto) could be one of the ... hip- and knee-replacement patients. , The panel voted 15 ...
    ... group homes in Los Angeles County after being charged with ... or drugs seven years later, according to a new RAND ... need to improve juvenile justice rehabilitation programs, according to the ... Health . , Studies rarely track juvenile offenders for so ...
    ... March 19 Today, South Dakota residents have reason ... 24th state in the nation, and the first in ... virtually everyone from secondhand smoke, in both public places ... lawmakers for making great strides in protecting health and ...
    ... DATATRAK International, Inc. (Nasdaq: DATA ), a ... for the clinical trials industry, today announced that a ... request for continued listing on The NASDAQ Capital Market, ... 1, 2009, the Company must evidence compliance with the ...
    ... CDC analysis finds almost half of all cases last year ... Tuberculosis cases reached an all-time low rate in the United ... , The U.S. Centers for Disease Control and Prevention reported ... cases per 100,000 people. , However, the CDC report also ...
    Cached Medicine News:Health News:Foundation for the Drug-Free World Honored with Seven ADDY Awards 2Health News:FDA Panel Backs New Anti-Clotting Drug 2Health News:Study finds most adolescents sent to group homes still involved with drugs/crime seven years later 2Health News:NASDAQ Panel Grants Extension to DATATRAK for Continued Listing on the NASDAQ Capital Market 2Health News:NASDAQ Panel Grants Extension to DATATRAK for Continued Listing on the NASDAQ Capital Market 3Health News:TB Still Declining in U.S., But at Slower Rate 2
    ... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
    ... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
    ... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
    ... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
    Medicine Products: