BEUDAMED
    FDA Enforcement Class II Ongoing

    LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFSST2323TV, LFSLFSST2323, LDFSLFSLED7TV5, LDFSLFSLED7TV55, LFSLED55, LFSLFSST23, LFSST2923TV, LFSST29TV, LFSST29, LFSST19WC, LFSST2923, LFSLFSST-1, LFSST292323, LFSST1919WC, LFS ST2319WC

    Recall: Z-0071-2024 · Reported October 11, 2023

    Enforcement

    Recall Number
    Z-0071-2024
    Event ID
    92999
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DKK Dai-Ichi Shomei Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 11, 2023
    Initiation Date
    August 23, 2023
    Classification Date
    October 5, 2023
    Address
    1 Chome 32-26, Sakashita, Itabashi, N/A, N/A, Japan

    Description

    LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFSST2323TV, LFSLFSST2323, LDFSLFSLED7TV5, LDFSLFSLED7TV55, LFSLED55, LFSLFSST23, LFSST2923TV, LFSST29TV, LFSST29, LFSST19WC, LFSST2923, LFSLFSST-1, LFSST292323, LFSST1919WC, LFS ST2319WC

    Reason

    The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the flat screen attached to the LFS flat screen system can rotate beyond the original angle limit and it could cause excessive force to be given to the spring shaft of the LFS bracket. Due to the excessive force given to the spring shaft, the spring shaft could break and shear off.

    Code Info

    Serial Numbers: 06087323 - 06087352, 06087353 - 06087354, 06081292 - 06081293, 06087448 - 06087449, 06087450 - 06087469, 06097595 - 06097596, 06107716 - 06107718, 06107719 - 06107728, 06107730, 06107731 - 06107732, 06111348 - 06111349, 06117855 - 06117856, 06117857 - 06117866, 06117868 - 06117868, 06111350 - 06111351, 06117949 - 06117949, 06117954 - 06117973, 06118031 - 06118032, 06128116 - 06128131, 06128172 - 06128176, 06128177 - 06128186, 06128187 - 06128188, 07010004, 07010002, 07010005 - 07010006, 07028436 - 07028441, 07030080 - 07030081, 07048491 - 07048495, 07058506 - 07058507, 07058508 - 07058512, 07068602 - 07068604, 07068605 - 07068607, 07068611 - 07068622, 07068609 - 07068610, 07068667 - 07068670, 07061479 - 07061484, 07078679 - 07078680, 07071485 - 07071488, 07071501, 07088741 - 07088742, 07081124, 07088766, 07098769 - 07098773, 07098767 - 07098768, 07098774 - 07098775, 07108885 - 07108889, 07108883 - 07108884, 07108876 - 07108882, 07108890 - 07108891, 07101533 - 07101534, 07129027 - 07129028, RA000182, RA000184, 08029174 - 08029183, 08029187 - 08029188, 08029189 - 08029190, 09111694, 10011776, 10011777, 10011778, 10011779, 10011780, 10011781, 10011782, 10051792, 10051794, 10051796, 10051798, 10051800, 10051802, 10051804, 100610044, 100610045, 100610046, 100610047, 100610048, 100610049, 100610050, 100610051, 100610052, 100610053, 101010180, 101010182, 101010184, 101010186, 101010188, 101010190, 101010192, 101210252, BM005435 - BM005435, BM006121 - BM006121, BM008121 - BM008127

    Distribution

    US States: MI

    Quantity

    256 units