BEUDAMED
    FDA Recall Terminated

    Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.

    Recall: Z-0766-2016 · Initiated July 22, 2015

    Recall

    Recall Number
    Z-0766-2016
    Event Number
    71764
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 22, 2015
    Terminated
    October 14, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.

    Reason

    If arm is not fastened securely it could fall down.

    Action

    Consignees were notified of the recall via letter sent certified return receipt on 7/22/2015. The letter informs customers that the Instruction for Use (IFU) requires the operator not to use the system and call for service, if a mechanical defect or malfunction is suspected. In this case, it is recommended not to position the Ceiling suspension with the Trauma arm directly above a patient as long as this Field Change Order is not yet installed. Philips plans to repair the affected systems. A Philips Service Engineer will contact customers as soon as the Field Action Kit is ready to be implemented. For questions, contact your local representative or use the Technical Support Line at 1-800-722-9377. When communicating with Philips regarding this issue, please reference Field Change Order 72000014.

    Distribution

    Distributed in the states of NY, WI, MA, AL, FL, GA, RI, CA, KS, and TX, and the countries of Canada, Australia, Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, New Zealand, Portugal, South Africa, Spain, and Switzerland.

    Quantity

    399 distributed, 262 are subject to this event