BEUDAMED
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    Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

    Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 700, B129382393. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.

    FDA Recall
    Terminated ·Steris Corporation·Product code FTD·February 23, 2010

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

    Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code FTD·January 9, 2004

    HANAULUX 2004 IXL cupola, P/N: 56076868 Intended to provide visible illumination for the surgical field or for the examination of the patient.

    FDA Recall
    Terminated ·MAQUET Inc.·Product code FTD·October 7, 2009

    STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm. Intended for local illumination of the operating and examination area of the patient in treatment rooms.

    FDA Recall
    Terminated ·Steris Corp·Product code FTD·September 11, 2009

    Drager Surgical Lights Sola 500 and Sola 700.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code FTD·August 26, 2009

    Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN3022EL and IF3022EL. (note only the 22'' lighthead is affected).

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light, 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF22, IF22B, IF22LH, IF22LHH-B, IF22M-S, IN22, IN22EL, IN22LH and IF22(EL).

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required

    FDA Recall
    Terminated ·Steris Corporation·Product code FTD·October 5, 2016

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

    Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C, LCA 10 - ARDLCA109002C, LCA 10 - ARDLCA109006C, LCA 10 - ARDLCA209008A, LCA 10 - ARDLCA209008C, LCA 10 - ARDLCA209009A, LCA 10 - ARDLCA209009C, LCA 10 - ARDLCA209010A, LCA 10 - ARDLCA209010C, LCA 10 - ARDLCA409000C, LCA 10 - ARDLCA409001C, LCA 10 - ARDLCA409002A, LCA 10 - ARDLCA409002C, LCA 10 - ARDLCA409003C, LCA 10 - ARDLCA409004A, LCA 10 - ARDLCA409004C, LCA 10 - ARDLCA409005C, LCA 10 DES - ARDLCA409001A, LCA 10 MOBILE - ARDLCA309008A, LCA 10 RAIL - ARDLCA409005A, LCA 10 WALL - ARDLCA109006A, LCA 40 - ARDLCA109001C, LCA 40 - ARDLCA208000A, LCA 40 - ARDLCA208000C, LCA 40 - ARDLCA208001A, LCA 40 - ARDLCA208001C, LCA 40 - ARDLCA209000A, LCA 40 - ARDLCA209000C, LCA 40 - ARDLCA209001A, LCA 40 - ARDLCA209001C, LCA 40 - ARDLCA209002A, LCA 40 - ARDLCA209002C, LCA 40 - ARDLCA209003A, LCA 40 - ARDLCA209003C, LCA 40 - ARDLCA209014A, LCA 40 - ARDLCA209014C, LCA 40 - ARDLCA209017A, LCA 40 - ARDLCA209017C, LCA 40 - ARDLCA209018A, LCA 40 - ARDLCA209018C, LCA 40 - ARDLCA209019A, LCA 40 - ARDLCA209019C, LCA 40 - ARDLCA209020A, LCA 40 - ARDLCA209020C, LCA 40 - ARDLCA209021A, LCA 40 - ARDLCA209021C, LCA 40 MOBILE - ARDLCA309009A, LCA 40 WALL - ARDLCA109001A, LCA 40GS - ARDLCA109009A, LCA 40GS - ARDLCA109009C, LCA 100 - ARDLCA109005A, LCA 100 - ARDLCA109005C, LCA 100 - ARDLCA219000A, LCA 100 MOBILE - ARDLCA309006A, LCA 100 MOBILE B - ARDLCA309007A, LCA 100 SAT - ARDSAT209004A, LCA 100 SAT - ARDSAT209005A, LCA 100 V - ARDLCA219000C, LCA 100DF - ARDLCA109008A, LCA 100DF - ARDLCA109008C, LCA 100DF - ARDLCA219003A, LCA 100DF - ARDSAT209008A, LCA 100DF - ARDSAT209009A, LCA 100DF V - ARDLCA219003C, LCA 50 - ARDLCA109004A, LCA 50 - ARDLCA109004C, LCA 50 - ARDLCA209012A, LCA 50 - ARDLCA209012C, LCA 50 - ARDSAT209002A, LCA 50 MOBILE - ARDLCA309004A, LCA 50 MOBILE B - ARDLCA309005A, LCA 50 SAT - ARDSAT209003A, LCA 50 WALL 11 - ARD2LCA00140A, LCA 50DF - ARDLCA109007A, LCA 50DF - ARDLCA109007C, LCA 50DF - ARDLCA209015A, LCA 50DF - ARDLCA209015C, LCA 50DF - ARDSAT209006A, LCA 50DF - ARDSAT209007A, LCA DUO 100 - ARDLCA219001A, LCA DUO 100 V - ARDLCA219001C, LCA DUO 100+50 - ARDLCA219002A, LCA DUO 100+50 V - ARDLCA219002C, LCA DUO 100+50DF - ARDLCA219005A, LCA DUO 100+50DF V - ARDLCA219005C, LCA DUO 100DF - ARDLCA219004A, LCA DUO 100DF V - ARDLCA219004C, LCA DUO 50 - ARDLCA209013A, LCA DUO 50 - ARDLCA209013C, LCA DUO 50DF - ARDLCA209016A, LCA DUO 50DF - ARDLCA209016C, LCA100 MOBILE UPGRADE - ARDLCA506006A, LCA100 UPGRADE - ARDLCA506004A, LCA100 UPGRADE 24V - ARDLCA506005A, LCA100 WALL UPGRADE - ARDLCA506007A, LCA50 UPGRADE - ARDLCA506000A, LCA50 UPGRADE 24V - ARDLCA506001A, LCA50 UPGRADE WALL MOUNTED - ARDLCA506003A, SAT LCA 100 - ARDSAT209004C, SAT LCA 100 - ARDSAT209005C, SAT LCA 100DF - ARDSAT209008C, SAT LCA 100DF - ARDSAT209009C, SAT LCA 50 - ARDSAT209002C, SAT LCA 50 - ARDSAT209003C, SAT LCA 50DF - ARDSAT209006C, SAT LCA 50DF - ARDSAT209007C, LCA 10 MOB - ARDLCA309000A, LCA 10 MOB - ARDLCA309000C, LCA 10 MOB - ARDLCA309002A, LCA 10 MOB - ARDLCA309002C, LCA 10 MOB - ARDLCA309008C, LCA 100 MOBILE - ARDLCA309006C, LCA 100 MOBILE B - ARDLCA309007C, LCA 40 MOB - ARDLCA309001A, LCA 40 MOB - ARDLCA309001C, LCA 40 MOB - ARDLCA309003A, LCA 40 MOB - ARDLCA309003C, LCA 40 MOB - ARDLCA309009C, LCA 40GS MOBILE - ARDLCA309010A, LCA 40GS MOBILE - ARDLCA309010C, LCA 50 MOBILE - ARDLCA309004C, LCA 50 MOBILE B - ARDLCA309005C,

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FTD·November 8, 2023

    Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII70SF - ARDPWT309007A, ROL PWDII70SF - ARDPWT309008A, ROL PWDII70SF - ARDPWT309015A, ROL PWDII70SF - ARDPWT309016A, ROL VCS40SF - ARDROL309031A, ROL VCS60SF - ARDROL309032A, ROL VST40SF - ARDROL309033A, ROL VST40SF - ARDROL309034A, ROL VST40SF B - ARDROL309037A, ROL VST60SF - ARDROL309035A, ROL VST60SF - ARDROL309036A, ROL VST60SF B - ARDROL309038A, ROL VCSII40SF - ARDROL309039A, ROL VCSII40SF - ARDROL309040A, ROL VCSII60SF - ARDROL309041A, ROL VCSII60SF - ARDROL309042A, ROL PWDII50SF - ARDROL309043A, ROL PWDII50SF - ARDROL309044A, ROL PWDII70SF - ARDROL309045A, ROL PWDII70SF - ARDROL309046A, ROL PWDII50SF - ARDROL309047A, ROL PWDII50SF - ARDROL309048A, ROL PWDII70SF - ARDROL309049A, ROL PWDII70SF - ARDROL309050A, ROL VSTII40SF - ARDROL309051A, ROL VSTII60SF - ARDROL309052A, ROL VSTII40SF - ARDROL309053A, ROL VSTII60SF - ARDROL309054A

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FTD·November 8, 2023