BEUDAMED
    FDA Recall Open, Classified

    Centricity PACS RA1000

    Recall: Z-1233-2022 · Initiated April 28, 2022

    Recall

    Recall Number
    Z-1233-2022
    Event Number
    90136
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    April 28, 2022
    Posted
    June 3, 2022
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Centricity PACS RA1000

    Reason

    Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.

    Action

    GE Healthcare notified consignees on about 04/28/2022 via letter titled "URGENT MEDICAL DEVICE CORRECTION." The letter outlined two safety issues and instructed customers to continue to use the device in accordance with the User Manuals, but for issue #1, do not rely on measurements displayed in the viewer. They should manually calibrate the image to create a measurement calibration reference and then perform necessary measurements. For issue #2, do not perform measurements on lossy images. In both instances, customers were requested to complete and return the acknowledgment form to [email protected]. A second letter was sent to customers on about 02/24/2023, to provide instructions for downloading the user manual addendum for CWeb.

    Distribution

    Worldwide distribution. Nationwide distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International distribution to Argentina, Australia, Austria, Bahamas, Belgium, Bermuda, Bolivia, Plurinational State of, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, South, Kuwait, Lebanon, Malaysia, Malta, Mexico, Namibia, Netherlands, Nigeria, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Qatar, Russia, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Bolivarian Republic of, Vietnam

    Quantity

    676 units