BEUDAMED
    FDA Recall Terminated

    Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

    Recall: Z-1607-2015 · Initiated March 11, 2015

    Recall

    Recall Number
    Z-1607-2015
    Event Number
    71135
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    LMC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 11, 2015
    Posted
    May 13, 2015
    Terminated
    June 26, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

    Reason

    The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned.

    Action

    Philips sent an Urgent - Medical Device Correction letter dated March 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm requested their customers to do the following: " If a misalignment on the top and/or bottom of the guide rail between the cabinet and carriage can be visually detected do not continue with the collimator exchange procedure, " If the misalignment is visually detected, be aware that the customer/user cannot remedy this issue and will require service interaction prior to the continued use of the system. " This letter should be placed in your User Documentation until otherwise notified. If you need any further information or support concerning this issue, please contact your local Philips Healthcare representative: For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter site ID or follow the prompts).

    Distribution

    Worldwide Distribution - US (nationwide) to the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and to the countries of : Australia, Austria, Belgium, Brazil, Canada, China, Costa Rica, Egypt, France, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Lebanon, Netherlands, Norway, Pakistan, Portugal, Russia, Singapore, South Korea, Spain,Thailand and United Kingdom.

    Quantity

    975 units