BEUDAMED
    FDA Recall Open, Classified

    Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.

    Recall: Z-1823-2025 · Initiated April 30, 2025

    Recall

    Recall Number
    Z-1823-2025
    Event Number
    96820
    Firm
    Maquet Cardiopulmonary Ag Kehler Str. 31 Rastatt Germany
    FEI Number
    3009507273
    Product Code
    DTQ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 30, 2025
    Posted
    May 27, 2025

    Description

    Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.

    Reason

    HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.

    Action

    An URGENT MEDICAL DEVICE RECALL (REMOVAL) notification dated April 2025 was mailed to consignees. The notification instructs consignees to identify and quarantine all affected product. Consignees should forward the provided recall notification to any individuals within their organization that utilize the affected device or to the entity it was distributed to. Consignees should complete and return the provided response form by email to [email protected]. Getinge Customer Service can be contacted at 888-943-8872 option 2 or by email at [email protected] to coordinate return of affected devices.

    Distribution

    Domestic: IL & MO. Foreign: Australia, Austria, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, South Korea, Poland, Russia, Saudi Arabia, Spain, Switzerland, Thailand.

    Quantity

    US: 2 units; OUS: 168 units