BEUDAMED
    FDA Recall Terminated

    Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.

    Recall: Z-2057-2015 · Initiated March 24, 2015

    Recall

    Recall Number
    Z-2057-2015
    Event Number
    71234
    Firm
    Hamilton Medical, Inc.
    FEI Number
    2937708
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 24, 2015
    Posted
    July 10, 2015
    Terminated
    December 23, 2015
    Address
    4990 Energy Way, Reno, NV, 89502-4123

    Description

    Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.

    Reason

    Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.

    Action

    *** Please note *** This is not a new recall. An error occurred, and this recall was originally classified as a class I on July 10, 2015. No further action is required. Hamilton Medical AG notified their customers with a letter dated February 19, 2015 and had a fix (SW 2.42) that was available as of February 20th 2015. Hamilton Medical proceeded to send out notification letters the 24th of March 2015 once they compiled the complete and validated list of customers that had the affected software. Customers with questions were instructed to call 800-426-6331, ext.215.

    Distribution

    Nationwide Distribution

    Quantity

    248