BEUDAMED
    FDA Recall Terminated

    TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study 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-0064-2017 · Initiated June 29, 2016

    Recall

    Recall Number
    Z-0064-2017
    Event Number
    74922
    Firm
    Winco Mfg., LLC
    FEI Number
    1027229
    Product Code
    FPP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 29, 2016
    Terminated
    September 27, 2017
    Address
    5516 SW 1st Ln, Ocala, FL, 34474-9307

    Description

    TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study 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.

    Action

    Customers were sent an Urgent: Medical Device Recall notification on 7/12/2016 for the specific models of the TransMotion (TMM) Stretcher chairs. The letter explained the reason for the recall and asked customers to take action. Customers are asked to follow the instruction in the Operator Manual for proper egress. Patients are not allowed to egress from the chair without assistance nor should they be left unattended. The chairs will be repaired on site; and, removal of the chair from service is not required with proper supervision and use. Customers are asked to complete the instructions for the acknowledgement form and return. The firm will contact the customers to arrange for repair. Questions regarding the field correction should be directed to the Customer Care department at 800-237-3377 or 352-854-2929 or e-mail [email protected]

    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