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FDA Recall/Product Labeling Update - ZOLL

    https://www.zoll.com/Product%20Notices/2021/08/27/FDA-Recall-Product-Labeling-Update
    ZOLL defibrillators meet stringent FDA premarket approval regulations English (US) ZOLL Webstore Careers Product Manuals ZOLL Payment Portal remedē ® System LifeVest ® Wearable Defibrillator ZOLL Data Systems Itamar Medical Products …

UPDATE -- Zoll LifeVest 4000 Wearable Cardioverter …

    https://www.fda.gov/medical-devices/safety-communications/update-zoll-lifevest-4000-wearable-cardioverter-defibrillator-software-update-potential-lack
    As previously communicated by both the FDA and Zoll, users should contact Zoll immediately and replace the device after “Call for Service—Message Code 102” first …

Automated External Defibrillators (AEDs) | FDA

    https://www.fda.gov/medical-devices/cardiovascular-devices/automated-external-defibrillators-aeds
    Dec 16, 2022

Class 2 Device Recall Zoll Medical X …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126205
    Recall Number: Z-1311-2014: Recall Event ID: 67749: 510(K)Number: K112432 K112761 K121367 Product Classification: Automated external defibrillators (non …

FDA: Two deaths linked to malfunction of Zoll's LifeVest …

    https://www.mobihealthnews.com/content/fda-two-deaths-linked-malfunction-zolls-lifevest-wearable-defibrillator
    Zoll Medical Corporation, which received FDA clearance a few years ago for both home and hospital versions of its wearable defibrillator LifeVest, is now dealing with …

Leonhard Lang Multi-function Defibrillation Electrodes …

    https://www.fda.gov/medical-devices/medical-device-recalls/leonhard-lang-multi-function-defibrillation-electrodes-will-not-work-zoll-aed-plus
    Reason for Recall Leonhard Lang is recalling the Skintact multifunction defibrillation electrode models DF59N and DF59NC due to a connector compatibility issue with the …

Product Notices - ZOLL

    https://www.zoll.com/Product%20Notices
    ZOLL defibrillators meet stringent FDA premarket approval regulations English (US) ZOLL Webstore Careers Product Manuals ZOLL Payment Portal remedē ® System LifeVest ® …

Medical Device Recalls | FDA

    https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
    The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that …

ZOLL to Support Customers Affected by the FDA Final

    https://www.zoll.com/news-releases/2020/02/28/zoll-to-support-customers-affected-by-the-fda-final-order-at-ems-today-2020
    February 28, 2020 — CHELMSFORD, MASS. — ZOLL ® Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices …

Medical Devices and Technology Solutions

    https://www.zoll.com/
    Resuscitation and Acute Critical Care Solutions. ZOLL ® is focused on improving outcomes with novel resuscitation and acute critical care technology. Our medical products and …



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