BEUDAMED
    FDA Enforcement Class II Terminated

    TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.

    Recall: Z-0066-2017 · Reported October 19, 2016

    Enforcement

    Recall Number
    Z-0066-2017
    Event ID
    74922
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Winco Mfg., LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 19, 2016
    Initiation Date
    June 29, 2016
    Classification Date
    October 9, 2016
    Termination Date
    September 27, 2017
    Address
    5516 SW 1st Ln, N/A, Ocala, FL, 34474-9307, United States

    Description

    TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.

    Reason

    Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.

    Code Info

    All identified serial numbers.

    Distribution

    Worldwide Distribution -- USA, including AR, CA, CO, CT, FL, GA, IL, KS, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, VA, WA, WI, and Puerto Rico; and the countries of Canada, Australia, Italy, Panama, Switzerland and Taiwan.

    Quantity

    264 Stretcher Chairs