BEUDAMED
    FDA Enforcement Class II Ongoing

    iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301

    Recall: Z-0443-2022 · Reported January 5, 2022

    Enforcement

    Recall Number
    Z-0443-2022
    Event ID
    88986
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AMO Manufacturing USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 5, 2022
    Initiation Date
    October 21, 2021
    Classification Date
    December 29, 2021
    Address
    510 Cottonwood Dr, Milpitas, CA, 95035-7403, United States

    Description

    iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301

    Reason

    Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights.

    Code Info

    G300 with Windows XP. G301 with Windows 7 Embedded System.

    Distribution

    US: CA, TX, FL, LA, MD, IA, MA, VA, SD, MN, MO, NC, TN, SC, WA, NV, OH, KY, IN, CO, NJ, OK, NH, UT, AR, NY, AK, ND, NE, IL, AL, HI, CT, DE, KS, GA, OR, MS, PA, MT, ME, MI, AZ, ID, WI, VT, NM, CA. OUS: Canada, Mexico, Russian Federation, Turkey, Brazil, Egypt, Iraq, Saudi Arabia, Jordan, Norway, Colombia, Germany, Malaysia, India, Oman, Azerbaijan, Canada, Slovakia, Lebanon, Spain, Ireland, Italy, South Korea, Bangladesh, Chile, Taiwan, Tunisia, Kazakhstan, Libya, Argentina, Singapore, Austria, Australia, Vietnam, Greece, Poland, Indonesia, Yemen, Great Britain, South Africa, Croatia, France, Czech Republic, Algeria, Thailand, Bulgaria, United Arab Emirates, Belgium, Japan, China, Nepal, Israel, Switzerland, Dominican Republic, Hong Kong, Portugal, Ecuador, Kuwait, Netherlands, Slovenia, Philippines

    Quantity

    711