BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISITE PACS

    MDR report key: 1465892 · Received May 27, 2009

    Report

    Report Number
    2954704-2009-00007
    Event Type
    Malfunction
    Date Received
    May 27, 2009
    Date of Event
    May 1, 2009
    Report Date
    May 1, 2009
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K063267
    Removal / Correction Number
    Z-0118-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ISITE PACS IS A SOFTWARE PRODUCT. WE ARE ABLE TO EVALUATE THE PRODUCT AT THE CUSTOMER SITE BY REMOTE ACCESS, AS WELL AS EVALUATE THE SAME PRODUCT VERSION IN-HOUSE. THIS PRODUCT VERSION IS CURRENT UNDER RECALL PER Z-0118-2009, (B)(4). THIS RECALL AFFECTS ISITE PACS VERSION 4.1.X - 4.1.45.2. WHEN DIFFERENT CR CASSETTE SIZES ARE USED WITH DIFFERENT VALUES PROVIDED BY THE MODALITIES IN PIXEL SPACING DICOM TAG (0028.0030), ISITE PACS DOES NOT USE THESE VALUES FOR MEASUREMENT CALCULATIONS. WHEN PERFORMING MEASUREMENTS IN ISITE PACS, THERE IS A POTENTIAL TO MISCALCULATE MEASUREMENTS UNDER THE FOLLOWING CONDITION: PIXEL SPACING (0028, 0030) AND IMAGER PIXEL SPACING (0018, 1164) DICOM TAG VALUES ARE BOTH PRESENT AND DIFFERENT. THERE ARE NO PROBLEMS WITH MANUALLY CALIBRATED IMAGES USING THE ISITE IMAGE CALIBRATION TOOL. LABELING INSTRUCTS CUSTOMERS TO MANUALLY CALIBRATE EACH PROJECTION X-RAY IMAGE USING A MARKER OF KNOWN SIZE PRESENT ON THE IMAGE ITSELF. THIS MARKER IS TO BE PLACED ON THE SAME PLANE, AS THE ANATOMY TO ENSURE THE MOST ACCURATE DISTANCE MEASUREMENTS. RECALL INITIATED TO ALIGN PRODUCT MEASUREMENT BEHAVIOR WITH CURRENT DICOM AND IHE MEASUREMENTS STANDARDS, BUT CUSTOMERS ARE STILL INSTRUCTED TO CALIBRATE/USE MARKER OF KNOWN SIZE FOR PROJECTION IMAGING. ORIGINAL MDR REPORT 2954704-2009-00006.

    Description of Event or Problem · 1

    NO REPORT OF PATIENT HARM OR INJURY RELATED TO THIS EVENT. CUSTOMER REPORTED WHEN INSTALLING NEW MODALITY AND VALIDATING FOR MEASUREMENTS PER LABELING, CANNOT GET MEASUREMENTS TO WORK AS EXPECTED. REQUESTED INFORMATION REGARDING DICOM TAG USAGE FOR MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISITE PACS ISITE PACS LLZ PHILIPS HEALTHCARE INFORMATICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1