BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).

    Recall: Z-1935-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1935-2020
    Event ID
    85549
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Medical Division of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 20, 2020
    Initiation Date
    April 7, 2020
    Classification Date
    May 8, 2020
    Termination Date
    January 22, 2021
    Address
    3800 E Centre Ave, N/A, Portage, MI, 49002-5826, United States

    Description

    Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).

    Reason

    Ambulance Cots may not meet crash test standard BS EN 1789

    Code Info

    Serial Numbers: 1909003700051 1909003700052 1909003700055 1909003700056 1909003700057 1909003700058 1909003700059 1909003700060 1909003700061 1909003700062 1909003700065 1909003700066 1909003700067 1909003700068 1909003700069 1909003700070 1909003700072 1909003700073 1909003700074 1909003700075 1909003700076 1909003700077 1909003700078 1909003700079 1909003700080 1909003700081 1909003700082 1909003700083 1909003700084 1909003700085 1909003700086 1909003700087 1909003700088 1909003700090

    Distribution

    Foreign: UK

    Quantity

    34 units