BEUDAMED
    FDA Recall Open, Classified

    AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR

    Recall: Z-0118-2023 · Initiated September 22, 2022

    Recall

    Recall Number
    Z-0118-2023
    Event Number
    90879
    Firm
    ZOLL Circulation, Inc.
    FEI Number
    3003793491
    Product Code
    DRM
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    September 22, 2022
    Posted
    October 21, 2022
    Address
    2000 Ringwood Ave, San Jose, CA, 95131-1728

    Description

    AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR

    Reason

    Due to increase in Li-Ion Battery failures

    Action

    On 09/22/2022, the firm sent an "MEDICAL DEVICE PRODUCT CORRECTION NOTICE" via First Class Mail to customers informing them that ZOLL Circulation observed an increase in battery complaints of fully charged batteries no powering on the AutoPulse Platform. Investigations revealed that batteries stored at elevated temperatures were failing and are potentially due to a supplier switching to an alternate electrical component and thermal variation within specification of a second electrical component. Customers are instructed to: 1. Complete the Customer Acknowledgement/No-Charge Battery Replacement Request Form and email it to [email protected] as soon as possible. 2. While waiting for the replacement batteries to arrive, do not store the affected batteries in a hot environment prior to use such as in a hot vehicle, in the sun, or in a hot room. Storing the affected batteries in a hot environment may prevent the batteries from powering on the AutoPulse Platform. Note that the affected batteries will power on the AutoPulse Platform after they are allowed to cool.

    Distribution

    U.S.: AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, RN, TX, UT, VA, VT, Virgin Islands, WA, WI, WV and WY. O.U.S.: United Arab Emirates, Austria, Australia, Azerbaijan, Brazil, Belarus, Canada, Switzerland, China, Costa Rica, Germany, Denmark, Egypt, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Moldova, Mexico, Malaysia, Netherlands, Norway, Panama, Philippines, Poland, Qatar, Romania, Russian, Saudi Arabia, Singapore, Slovenia, Taiwan, and Vietnam.

    Quantity

    6,353 batteries