BEUDAMED
    FDA Enforcement Class II Terminated

    Achilles Express Bone Sonometer

    Recall: Z-0113-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0113-2020
    Event ID
    83811
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2019
    Initiation Date
    September 3, 2019
    Classification Date
    October 10, 2019
    Termination Date
    February 16, 2021
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    Achilles Express Bone Sonometer

    Reason

    Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.

    Code Info

    System ID: ACE34924, AWE11358, ACE34606, ACE34652, ACE34651, AWE11894, AWE1196, ACE34927, ACE886H, AWE10447, AWE11047, AWE11098, AWE11304, AWE11312, AWE11317, AWE11381, AWE11285, ACH+12937, ACH+12932, ACH+12939, ACH+12935, ACH+12942, ACH+12936, ACH+12943, ACH+12938, ACH+12945, ACH+12940, ACH+12947, ACH+12952, ACH+12948, ACH+12871, ACH+12933, ACH+12872, ACH+12931, ACH+12290, ACH+12955, ACH+12975, ACH+12978, ACH+12983GA, ACH+12986, 2798401, 2815867, 2858452, 2876988, 2693419, 0002722584A, ACH10439, ACH31114, ACH10346, ACH10364, ACH10393, 828330086, 828330087,828330097, 828330098, 828330115, 828330091, 828330099, 828330119, 828330117, 83033100400411, 83033100024611, 83033000014510, 83033005000787, 83033004563599, 83033005000579, 83033005002887, 83033005003917, 83033000410110, 83033000415311, 83033004190909, 83033005000938, 83033005000978, 83033005002399, 83033009010429, 0002765007, 0002549803A, 83033000000018, 83033001234568, 83033009010046, 83033206010165, 83033209010165, 83033240415211, 83033245000577, 83033000011810, 0002830095, 0002960988, 0004225139, 0004241217, 83033820408610, 83033825000089, 83033825000098, 83033825000359, 83033825100325, 83033825101736, 83033826101736, 83033860068211, 83033200414211, 83033200012210, 83033200407710, 83033200407711, 83033200407712, 83033200413211, 83033205001468, 83033205105099, 83033205355099, 83033200012010, 83033200024711, 83033205104326, 83037200413111, 83033205002496, 83033205000068, 83033205004238, 83033605001326, 83033205102295, 83033209026036, 83033209026076, 0002540710, 0002767636, 0002767636A, 0002767636B, 0002767636C, 0002767636D, 83033005102305, 83033825000156, 83033205101507, 83033205101456, 83033205007588, 83033805004289, 83033205004228, 83033065000199, 83033205002037, 83033005105137, 83033806695010, 83033805001126, 0002790424, 83033600000008, 83033600308711, 83033605105157, IE1574LU01, A179802601, A258022402, 834334061, 834334010, 834334026, 834334028, 834334029, 834334004, 834334007, 834334006, 834334054, 834334055, 083433NZM30581, 083433NZM30585, 083433NZM30662, 83033008881210, 83033008881211, 0002501112B, 0002508220A, 0002791713, 0002818827, 0002732489, 0002739062, ACH+11056, 843334009, 084333NZM31123, 843334218, SA2155XR01, 847334059, 6073UL0164, 83033805200666, 853330027, 853330028, 853330029, 853330030, 853330031, 853330032, 853330033, 853330034, 853330057, 853330059, 853330060, 853330061, 853330062, 853330065, 853330072, 853330074, 853330080, 853330081, 853330082, 853330083, 853330084, 853330085, 856330003, 856330029, 856330002, 856330013, 856330019, 856330014, 856330016, 085633NZM10512, 085633NZM10524, 085633NZM11414, 085633NZM11693, 085633NZM12132, 085633NZM12134, 085633NZM12754, 085633NZM12755, 085633NZM12756, 856330009, 856330034, 856330007, 856330008, 856330004, 20181RAD02, 20181RAD03, 10423RAD02, 10423RAD03, 10423RAD04, 10423RAD05, 10423RAD06, 10423RAD07, 10423RAD08, 10423RAD09, 10423RAD10, 10423RAD11, 10423RAD12, 10423RAD13, 20356RAD03, 20357RAD01, 10422RAD02, 20355RAD02, 20109RAD02, 21001RAD01, 21008RAD01, 21008RAD02, 21008RAD03, 20358RAD01, 0002593515X, 0002638962, 859334009

    Distribution

    Nationwide distribution to AZ, GA, MT, NC, NJ, NY, OH, WI. International distribution to Australia, Bahrain, Bangladesh, Brazil, Cambodia, Chile, China, Colombia, Cyprus, Hong Kong, India, Iraq, Ireland, Italy, Kuwait, Lebanon, Malaysia, Mauritius, Mexico, MEXICO, Myanmar, Nepal, Oman, Panama, Peru, Philippines, Saudi Arabia, Singapore, Sri Lanka, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay, Vietnam

    Quantity

    241 devices