BEUDAMED
    FDA Recall Terminated

    PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare, Inc. A computed radiography image processing system.

    Recall: Z-3205-2011 · Initiated July 27, 2011

    Recall

    Recall Number
    Z-3205-2011
    Event Number
    59473
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 27, 2011
    Posted
    September 14, 2011
    Terminated
    January 12, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare, Inc. A computed radiography image processing system.

    Reason

    The mirror icon on the bottom of each image could be interpreted as a RIGHT marker for side indication if the image is mirrored again within a PACS system. This could potentially lead to a misdiagnosis

    Action

    Philips Healthcare Inc. sent out "Urgent --Medical Device Correction" notices dated June 10, 2011 to all affected customers. The letter described the product and problem. Customers were informed the "burned-in Mirror-Icon" may be misinterpreted as a Right marker. Customers are advised to preferably use lead markers during each X-ray acquisition or alternatively electronic annotations on each image for side indication. The presentation of these markers within each image will clearly show the difference between the intended Left/Right indication and the little mirror ICON. Philips will install improved software that prevents the misinterpretation of the symbol and will schedule the installation of the updated software. For questions on this recall call Phillips Healthcare Inc. at 978-687-1501.

    Distribution

    Worldwide Distribution: Nationwide distribution; and including the countries of Albania, Angola, Argentina, Australia, Austria, Azerbaijan, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Croatia, Denmark, Egypt, France, Germany, Ghana, Greece, Greece, Haiti, Hungary, Indonesia, Iraq, Israel, Italy, Kazakhstan, Kenya, Latvia, Libya, Liechtenstein, Lithuania, Malawi, Malta, Martinique, Mexico, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Philippines, Portugal, Puerto Rico, Romania, Russia, Saudi-Arabia, Serbia, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Tanzania, Thailand, Tschech. Rep, Turkey, Turkmenistan, UAE, Uganda, and United Kingdom.

    Quantity

    197 units