BEUDAMED
    FDA Recall Terminated

    Philips Medical System Allura Xper X-Ray Angiographic

    Recall: Z-1120-2015 · Initiated June 6, 2014

    Recall

    Recall Number
    Z-1120-2015
    Event Number
    70011
    Firm
    Philips Medical Systems, Inc.
    FEI Number
    1218950
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    June 6, 2014
    Posted
    March 2, 2015
    Terminated
    October 15, 2021
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips Medical System Allura Xper X-Ray Angiographic

    Reason

    In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.

    Action

    Philips Medical Planned Action: 1. The affected customers will be sent a customer notification letter that identifies the software corrective actions and indicates that these corrective actions will be provided to the end-user free of charge 2. A mandatory Field Change Order with reference FCO72200270 will be released that requires Philips field service engineers to install Software release R7.2.8 which addresses the buzzer issue. The expected date of this FCO will be February 2015. The software release will contain updated timer function code to correct the intermittent fluoroscopy timer malfunction. 3. Philips Healthcare Field Service Engineers will schedule an appointment with customers to install the software update. 4. The software solutions will be rolled out consecutively, each within a maximum completion time of 6 months. The software releases will be corrected in descending order of the number of affected systems in the field, with approximately 80% of the total installed base corrected by 4 2015.

    Distribution

    Worldwide Distribution - USA nationwide including Puerto Rico, Austria, Azerbaijan, Australia, Algeria, Argentina, Albania, Brazil, Belgium, Bangladesh, Bahamas, Bulgaria, Cambodia, Chile, Canada, China, Croatia, Czech Republic, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Reunion, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Saudi Arabia, Switzerland, Syria, Taiwan, Thailand, France, Dominican Republic, Colombia, Turkey, Germany, Greece, Hong Kong, Denmark, Ecuador, Egypt, Estonia, Finland, Vietnam, Russian Federation, Iran, Iraq, Ireland, Israel, Italy, India, Indonesia, Japan, Jordan, Kenya, South Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Moldavia, Mongolia, Morocco, Nepal, Ukraine, United Arab Emirates, and United Kingdom

    Quantity

    7439