BEUDAMED
    FDA Recall Terminated

    MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.

    Recall: Z-0082-2014 · Initiated September 12, 2013

    Recall

    Recall Number
    Z-0082-2014
    Event Number
    66336
    Firm
    Maquet Medical Systems USA
    FEI Number
    3008355164
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    September 12, 2013
    Posted
    October 25, 2013
    Terminated
    June 7, 2017
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.

    Reason

    It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." The alarm will occur-upon start up or when the main power supply is unplugged from the main power source. The human machine interface touch screen of the CARDIOHELP-i device may gradually become black due to the human machine interface (HMI) back light shutting down.

    Action

    MAQUET issued their customers "Urgent-Medical Device Field Correction" notices/Customer Fax Response forms dated September 16, 2013 via FedEx on September 16, 2013. The notification informs the customer of the issue with the product; how to identified affected product; and the action needed to be taken by the customer. The field correction includes service on the affected product. Authorized MAQUET Service Technicians will service the affected product to correct the issue. Customers were requested to complete and fax back (or email a scanned copy) of the enclosed response form. Customers could contact their local field representative or the MAQUET Customer Service line at 1.888.627.8383 (press option 2 followed by option 2) Monday through Friday, 8am to 6pm EST. For questions regarding this recall call 973-709-7000.

    Distribution

    Nationwide Distribution including AZ, FL, CO, TX, OH, VA, MN, WI, SC, IL, ND, UT, CA, OR, NY, IA, CT, SD, MI, HI, AL, MD, KS, MO

    Quantity

    63