BEUDAMED
    FDA Recall Terminated

    Philips Digital Diagnost Rel 3, a radiographic system, digital Intended use: Radiographic system, digital

    Recall: Z-0313-2012 · Initiated November 1, 2011

    Recall

    Recall Number
    Z-0313-2012
    Event Number
    60323
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 1, 2011
    Posted
    November 30, 2011
    Terminated
    January 17, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips Digital Diagnost Rel 3, a radiographic system, digital Intended use: Radiographic system, digital

    Reason

    Missing a small, metal protective cover on the bottom side of the control handle for the ceiling suspension. exposes printed circuit

    Action

    The firm, Philips Healthcare, sent a "URGENT - Field Safety Notice" letter dated October 25, 2011, to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed: Do not place your hand in the open slot below the Control Handle and ensure that no patient places his/her hands the opening; review the following information with all members of their staff who need to be aware of the contents of this communication, and retain a copy with the equipment instruction for use. Philips has issued a Field Change order instructing Service Engineers to check affected systems and install the cover where it is missing free of charge. If you need any further information or support concerning this issue call 978-659-4519.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: NC, SC, TX, and WV; and countries of: Australia, Austria,Canada, Germany, Italy, Netherlands, Sweden, and Switzerland.

    Quantity

    28 (7 US; 2 Canada; 19 OUS)