BEUDAMED
    FDA Recall Terminated

    BrightView XCT Gamma Camera, 3/4". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

    Recall: Z-2949-2011 · Initiated June 15, 2011

    Recall

    Recall Number
    Z-2949-2011
    Event Number
    59252
    Firm
    Philips Medical Systems
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 15, 2011
    Posted
    August 4, 2011
    Terminated
    February 15, 2013
    Address
    3860 N 1st St, San Jose, CA, 95134-1702

    Description

    BrightView XCT Gamma Camera, 3/4". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

    Reason

    Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer, XCT acquisition, Pixel Mask for image reconstruction and table moving incorrectly.

    Action

    Philips Medical Systems, Inc. set a "Customer Information" letter dated July 8, 2011 to all affected customers. The letter informed them of an upcoming software updated (version 2.5). For questions please contact 800-722-9377 (option 5).

    Distribution

    Worldwide Distribution: (USA) Nationwide distribution and the countries of Greece, Australia, Belgium, China, Czech Republic, France, Germany, Indonesia, Israel, Japan, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Slovakia, South Korea, Spain, Switzerland, Taiwan U.A.E., and the UK.

    Quantity

    213 units