BEUDAMED
    FDA Recall Terminated

    Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. The Capsule Neuron Docking Station provides connection for the Capsule Neuron UMPC which is a bedside device that enables automatic collection of vital signs data that can connect to the hospital network through a wired Ethernet connection or via a standard 802.11 b/g/n wireless network.

    Recall: Z-2377-2012 · Initiated August 10, 2012

    Recall

    Recall Number
    Z-2377-2012
    Event Number
    62844
    Firm
    Capsule Tech Inc.
    FEI Number
    3006648320
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 10, 2012
    Posted
    September 13, 2012
    Terminated
    April 22, 2015
    Address
    300 Brickstone Sq, Suite 203, Andover, MA, 01810-1492

    Description

    Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. The Capsule Neuron Docking Station provides connection for the Capsule Neuron UMPC which is a bedside device that enables automatic collection of vital signs data that can connect to the hospital network through a wired Ethernet connection or via a standard 802.11 b/g/n wireless network.

    Reason

    Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron

    Action

    The firm, Capsule Tech, sent a recall letter dated August 10,2012 to its customers. The letter described the product, problem and actions to be taken. Capsule is sending field correction kits to customers with instructions. Capsule's Professional Services team will contact the customers to schedule shipment of their kit. Final shipments of the field correction kits will be completed by Oct 2012. If you have any questions or concerns, contact your professional services representative and/or call in US: 978-482-2340 or France: +33 153-34-14-00.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Denmark, France, Germany, Netherlands and UK.

    Quantity

    12,448 units