BEUDAMED
    FDA Recall Open, Classified

    CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.

    Recall: Z-0420-2024 · Initiated October 10, 2023

    Recall

    Recall Number
    Z-0420-2024
    Event Number
    93197
    Firm
    Maquet Medical Systems USA
    FEI Number
    3008355164
    Product Code
    DTQ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 10, 2023
    Posted
    December 7, 2023
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.

    Reason

    Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia.

    Action

    On October 10, 2023, the firm issued an Urgent Medical Device Removal letter to all affected consignees. Customers should examine their inventory to determine if they have any affected CARDIOHELP Emergency Drives in their inventory. A representative from Getinge will contact customers to ensure they have received the recall information and have taken the necessary actions. Getinge will arrange the supply of loaner replacements where needed and arrange for the return of affected devices for repair. " You may also request loaner Emergency Drive(s) from Getinge Technical Support at (888) 943-8872 (select option 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) " If you have affected product that is currently being used in patient treatment, inform Getinge immediately at (888) 943-8872, option 1, option 1. Please ensure that an alternate means of emergency support is available at all times, which may include a nonaffected Emergency Drive (if available) or a fully charged backup CARDIOHELP console. If you have any questions, please contact Getinge Technical Support at (888) 943-8872 (select option 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). ***Updated 1/8/24*** Additional serial numbers were added to the scope.

    Distribution

    US Nationwide - Worldwide Distribution: Domestic distribution to: AL, CA, DC, FL, HI, IA, IL, IN, KY, MD, MI, MN, MO, NE, OH, SC, VA Foreign distribution to: Austria, Australia, Brazil, Canada, Chile, China, Czech Republic, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Jordan, Mexico, New Zealand, Pakistan, Portugal, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom

    Quantity

    Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S.