BEUDAMED
    FDA Recall Terminated

    Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 4535-602-79781; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, OH The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel

    Recall: Z-2868-2011 · Initiated June 3, 2011

    Recall

    Recall Number
    Z-2868-2011
    Event Number
    59077
    Firm
    Philips Medical Systems
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 3, 2011
    Posted
    July 22, 2011
    Terminated
    November 6, 2012
    Address
    3860 N 1st St, San Jose, CA, 95134-1702

    Description

    Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 4535-602-79781; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, OH The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel

    Reason

    The gap between the two parts of the table may permit pinches to occur on either patient's skin or other body parts; it has the potential for serious injury if a patient's finger is caught between the pallet and patient table resulting in broken finger bone.

    Action

    Philips Healthcare issued a Customer Information letter (Field Change Order (#88200402)) dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the instruction for use for their system, which states "Monitor the patient and the system vigilantly during any system motions to make sure that ...accessories, equipment, and all ojbects such as hair, jewelry, or neckties-remain clear of any moving camera and imaging table parts. For additional information, customers were istructed to see the BrightView SPECT instructions for Use, section 2.2 - Safety Warnings and Precautions and Safety and Information Labels. Philips Healthcare will notify all affected customers and will install a sticker through an Action for Performance - Proactive Field Change Order (FCO) to resolve the issue. For customers in North America who require further information or support contact Customer Care Solutions Center at 1-800-722-9377, Select Option 5. In all other countries the local Philips Healthcare office should be contacted.

    Distribution

    Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Australia, Austria, Bahrain, Belgium, Brazil, China, Chile, Columbia, Czech Republic, Denmark, Dominican Republic, Egypt, France, Greece, India, Iran, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, Peru, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Switxerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.