BEUDAMED
    FDA Recall Terminated

    HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients

    Recall: Z-0151-2016 · Initiated April 22, 2014

    Recall

    Recall Number
    Z-0151-2016
    Event Number
    72319
    Firm
    Hamilton Medical, Inc.
    FEI Number
    2937708
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 22, 2014
    Posted
    November 4, 2015
    Terminated
    August 24, 2017
    Address
    4990 Energy Way, Reno, NV, 89502-4123

    Description

    HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients

    Reason

    Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult).

    Action

    Hamilton Medical issued a letter dated April 22, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that their Hamilton Medical Account Manager would contact them to coordinate the deactivation of the Ventilation Suppression feature. Customers were asked to review the Medical Device Field Safety Corrective Action. Customers with questions were instructed to call 800-426-6331, Ext 215.

    Distribution

    Nationwide Distribution

    Quantity

    1128