BEUDAMED
    FDA Enforcement Class I Ongoing

    Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.

    Recall: Z-1227-2022 · Reported June 15, 2022

    Enforcement

    Recall Number
    Z-1227-2022
    Event ID
    90076
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2022
    Initiation Date
    April 18, 2022
    Classification Date
    June 6, 2022
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.

    Reason

    Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.

    Code Info

    Field Replacement Unit kits PN: 1009-5682-000-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V) and PN: 5856787-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V PAIR).

    Distribution

    Worldwide Distribution: US (nationwide) to AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and OUS (internationally) to Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Cote D'Ivoire, Mexico, Uruguay, United Kingdom, United Arab Emirates, Turkey, Thailand, Tanzania, Sweden, Spain, Singapore, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Panama, Omar, Norway, Nigeria, Nicaragua, New Zealand, Netherlands, Malaysia, Latvia, Kuwait, Korea, Kenya, Kazakhstan, Japan, Italy, Ireland, Indonesia, India, Hungary, Germany, France, Finland, Estonia, Egypt, Ecuador, Denmark, Czech Republic.

    Quantity

    88,379 batteries