BEUDAMED
    FDA Recall Terminated

    Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH

    Recall: Z-1598-2015 · Initiated March 13, 2015

    Recall

    Recall Number
    Z-1598-2015
    Event Number
    71190
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 13, 2015
    Posted
    May 12, 2015
    Terminated
    June 26, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH

    Reason

    During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition.

    Action

    Philips sent an Customer Information letter dated March 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to : 1. Do not lubricate the clutch(es) with oil, grease or any other type of lubricant.. 2. Follow product Instructions For Use (IFU), CARDIO. SOLUS, ADAC VERTEX, AND ADAC VERTEX PLUS WITH ATLAS USERS MANUAL, 9201-0227E-ENG, REV A- General Precautions that instructs user to monitor the patient during scanning. 3. Follow product Instructions For Use (IFU), CARDIC, SOLUS, ADAC VERTEX, AND ADAC VERTEX PLUS WITH ATLAS USER'SMANUAL, 9201-0227E-ENG, REV A- Emergency Patient Removal, Section Safety and Regulatory Agency Compliance, page 2-11, instruction(s) on emergency patient removal. 4. Ensure completion of product Preventive Maintenance (PM) procedure requiring inspection of the radius drive clutches every 3 months for contamination and replacement if contaminated and, testing of the gantry system. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.

    Distribution

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

    Quantity

    918 units