Lamp, Surgical

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2024-07-05Open, ClassifiedUnder Investigation by firm

  Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)

  Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads

• 2024-07-05Open, ClassifiedUnder Investigation by firm

  iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad Surgical Lights)

  Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads

• 2024-01-19Open, ClassifiedEquipment maintenance

  Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A, PWDII755SF - ARDPWT629104A, PWDII775DF - ARDPWT629105A, PWDII775SF - ARDPWT629106A, PWDII50DF - ARDPWT629109A, PWDII50SF - ARDPWT629110A, PWDII50SF - ARDPWT629111A, PWDII55DF - ARDPWT629112A, PWDII55SF - ARDPWT629113A, PWDII70DF - ARDPWT629114A, PWDII70DF - ARDPWT629115A, PWDII70SF - ARDPWT629116A, PWDII70SF - ARDPWT629117A, PWDII75DF - ARDPWT629118A, PWDII75SF - ARDPWT629119A, PWDII50DF - ARDPWT629120A, PWDII50SF - ARDPWT629121A, PWDII50SF - ARDPWT629122A, PWDII55DF - ARDPWT629123A, PWDII55SF - ARDPWT629124A, PWDII70DF - ARDPWT629125A, PWDII70DF - ARDPWT629126A, PWDII70SF - ARDPWT629127A, PWDII70SF - ARDPWT629128A, PWDII75DF - ARDPWT629129A, PWDII75SF - ARDPWT629130A, PWDII50DF - ARDPWT629131A, PWDII50SF - ARDPWT629132A, PWDII50SF - ARDPWT629133A, PWDII55DF - ARDPWT629134A, PWDII55SF - ARDPWT629135A, PWDII70DF - ARDPWT629136A, PWDII70DF - ARDPWT629137A, PWDII70SF - ARDPWT629138A, PWDII70SF - ARDPWT629139A, PWDII75DF - ARDPWT629140A, PWDII75SF - ARDPWT629141A, PWDII50DF - ARDPWT629142A, PWDII50SF - ARDPWT629143A, PWDII50SF - ARDPWT629144A, PWDII55DF - ARDPWT629145A, PWDII55SF - ARDPWT629146A, PWDII70DF - ARDPWT629147A, PWDII70DF - ARDPWT629148A, PWDII70SF - ARDPWT629149A, PWDII70SF - ARDPWT629150A, PWDII75DF - ARDPWT629151A, PWDII75SF - ARDPWT629152A, PWDII50DF - ARDPWT629154A, PWDII50DF - ARDPWT629155A, PWDII77SF - ARDPWT629156A, PWDII50DF - ARDPWT639001A, PWDII50DF - ARDPWT639002A, PWDII50DF - ARDPWT639003A, PWDII50DF - ARDPWT639004A, PWDII50SF - ARDPWT639006A, PWDII50SF - ARDPWT639007A, PWDII50SF - ARDPWT639008A, PWDII50SF - ARDPWT639009A, PWDII70DF - ARDPWT639011A, PWDII70DF - ARDPWT639012A, PWDII70DF - ARDPWT639013A, PWDII70DF - ARDPWT639014A, PWDII70SF - ARDPWT639016A, PWDII70SF - ARDPWT639017A, PWDII70SF - ARDPWT639018A, PWDII70SF - ARDPWT639019A, PWDII70DF - ARDPWT639021A, PWDII50DF - ARDPWT639022A, PWDII50DF - ARDPWT639023A, PWDII50DF - ARDPWT639024A, PWDII50DF - ARDPWT639025A, PWDII50SF - ARDPWT639027A, PWDII50SF - ARDPWT639028A, PWDII50SF - ARDPWT639029A, PWDII50SF - ARDPWT639030A, PWDII70DF - ARDPWT639032A, PWDII70DF - ARDPWT639033A, PWDII70DF - ARDPWT639034A, PWDII70DF - ARDPWT639035A, PWDII70SF - ARDPWT639037A, PWDII70SF - ARDPWT639038A, PWDII70SF - ARDPWT639039A, PWDII70SF - ARDPWT639040A, PWDII70DF - ARDPWT639042A, PWDII50DF - ARDPWT639043A, PWDII50DF - ARDPWT639044A, PWDII50DF - ARDPWT639045A, PWDII50DF - ARDPWT639046A, PWDII55DF - ARDPWT639048A, PWDII55DF - ARDPWT639049A, PWDII55DF - ARDPWT639050A, PWDII75DF - ARDPWT639052A, PWDII75DF - ARDPWT639053A, PWDII75DF - ARDPWT639054A, PWDII50SF - ARDPWT639056A, PWDII50SF - ARDPWT639057A, PWDII50SF - ARDPWT639058A, PWDII50SF - ARDPWT639059A, PWDII55DF - ARDPWT639061A, PWDII55DF - ARDPWT639063A, PWDII55SF - ARDPWT639064A, PWDII55SF - ARDPWT639066A, PWDII55SF - ARDPWT639067A, PWDII55SF - ARDPWT639068A, PWDII55SF - ARDPWT639069A, PWDII70DF - ARDPWT639071A, PWDII70DF - ARDPWT639072A, PWDII70DF - ARDPWT639073A, PWDII70DF - ARDPWT639074A, PWDII70DF - ARDPWT639076A, PWDII70SF - ARDPWT639077A, PWDII70SF - ARDPWT639078A, PWDII70SF - ARDPWT639079A, PWDII70SF - ARDPWT639080A, PWDII75DF - ARDPWT639082A, PWDII75DF - ARDPWT639084A, PWDII75SF - ARDPWT639086A, PWDII75SF - ARDPWT639088A, PWDII75SF - ARDPWT639089A, PWDII75SF - ARDPWT639090A, PWDII75SF - ARDPWT639091A, PWDII77DF - ARDPWT639093A, PWDII77DF - ARDPWT639095A, PWDII77DF - ARDPWT639096A, PWDII77DF - ARDPWT639098A, PWDII77DF - ARDPWT639099A, PWDII77SF - ARDPWT639101A, PWDII77SF - ARDPWT639103A, PWDII77SF - ARDPWT639104A, PWDII77SF - ARDPWT639105A, PWDII77SF - ARDPWT639106A, PWDII50DF - ARDPWT639108A, PWDII50DF - ARDPWT639109A, PWDII50DF - ARDPWT639110A, PWDII50DF - ARDPWT639111A, PWDII55DF - ARDPWT639113A, PWDII55DF - ARDPWT639114A, PWDII55DF - ARDPWT639115A, PWDII75DF - ARDPWT639117A, PWDII75DF - ARDPWT639118A, PWDII75DF - ARDPWT639119A, PWDII50SF -

  A potential for a light system to fall in the operating room.

• 2024-01-19Open, ClassifiedEquipment maintenance

  Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP - ARDROL309001C, ROL B FOR VLT600SF STP - ARDROL309003A, ROL B FOR VLT600SF STP - ARDROL309003C, ROL FOR VLT400SF STP - ARDROL309000A, ROL FOR VLT400SF STP - ARDROL309000C, ROL FOR VLT600SF STP - ARDROL309002A, ROL FOR VLT600SF STP - ARDROL309002C, VCS40 ROL - ARDROL309024A, VCS40 ROL - ARDROL309024C, VCS40 ROL - ARDROL309028A, VCS40 ROL - ARDROL309028C, VCS60 ROL - ARDROL309025A, VCS60 ROL - ARDROL309025C, VCS60 ROL - ARDROL309029A, VCS60 ROL - ARDROL309029C, VST40 - ARDROL309016A, VST40 - ARDROL309016C, VST40 - ARDROL309017A, VST40 - ARDROL309017C, VST40 - ARDROL309020A, VST40 - ARDROL309020C, VST40 - ARDROL309022A, VST40 - ARDROL309022C, VST60 - ARDROL309018A, VST60 - ARDROL309018C, VST60 - ARDROL309019A, VST60 - ARDROL309019C, VST60 - ARDROL309021A, VST60 - ARDROL309021C, VST60 - ARDROL309023A, VST60 - ARDROL309023C, VCS40DF - ARDVCS209001A, VCS40DF - ARDVCS209001C, VCS40DF - ARDVCS209010A, VCS40DF - ARDVCS209012A, VCS40DF - ARDVCS209021A, VCS40SF - ARDVCS209000A, VCS40SF - ARDVCS209000C, VCS40SF - ARDVCS209011A, VCS40SF 08 - ARDVCS209046A, VCS44DF - ARDVCS209005A, VCS44DF - ARDVCS209005C, VCS44DF - ARDVCS209016A, VCS44SF - ARDVCS209004A, VCS44SF - ARDVCS209004C, VCS44SF - ARDVCS209015A, VCS44SFDF - ARD2VCS00040A, VCS60DF - ARDVCS209003A, VCS60DF - ARDVCS209003C, VCS60DF - ARDVCS209014A, VCS60DF - ARDVCS209022A, VCS60DF 11 - ARDVCS209047A, VCS60SF - ARDVCS209002A, VCS60SF - ARDVCS209002C, VCS60SF - ARDVCS209013A, VCS64DF - ARDVCS209007A, VCS64DF - ARDVCS209007C, VCS64DF - ARDVCS209018A, VCS64SF - ARDVCS209006A, VCS64SF - ARDVCS209006C, VCS64SF - ARDVCS209017A, VCS64SFDF - ARD2VCS00010A, VCS64SFDF 1011 - ARDVCS209048A, VCS66DF - ARDVCS209009A, VCS66DF - ARDVCS209009C, VCS66DF - ARDVCS209020A, VCS66SF - ARDVCS209008A, VCS66SF - ARDVCS209008C, VCS66SF - ARDVCS209019A, VCSII40DF SB08 - ARDVCS209023A, VCSII40DF SB11 - ARDVCS209024A, VCSII40SF SB11 - ARDVCS209025A, VCSII44DF SB0810 - ARDVCS209026A, VCSII44SF SB1011 - ARDVCS209027A, VCSII60DF SB08 - ARDVCS209028A, VCSII60SF SB11 - ARDVCS209029A, VCSII64DF SB0810 - ARDVCS209030A, VCSII64SF SB1011 - ARDVCS209031A, VCSII66DF SB0810 - ARDVCS209032A, VCSII66SF SB1011 - ARDVCS209033A, VCSII40DF TK SB08 - ARDVCS209034A, VCSII40DF TK SB11 - ARDVCS209035A, VCSII40SF TK SB11 - ARDVCS209036A, VCSII44DF TK SB0810 - ARDVCS209037A, VCSII44SF TK SB1011 - ARDVCS209038A, VCSII60DF TK SB08 - ARDVCS209039A, VCSII60SF TK SB11 - ARDVCS209040A, VCSII64DF TK SB0810 - ARDVCS209041A, VCSII64SF TK SB1011 - ARDVCS209042A, VCSII66DF TK SB0810 - ARDVCS209043A, VCSII66SF TK SB1011 - ARDVCS209044A, VCS40DF SAT 12 - ARD2VCS00070A, VCSII40SF SB08 - ARDVCS209049A, VCSII64SFDF SB1011 - ARDVCS209050A, SAT VLT400D - ARD2SAT00080C, SAT VLT400D - ARD2SAT00100C, SAT VLT400DF - ARD2SAT00080A, SAT VLT400DF - ARD2SAT00100A, SAT VLT400S - ARD2SAT00030C, SAT VLT400S - ARD2SAT00040C, SAT VLT400SF - ARD2SAT00040A, SAT VLT40DF - ARD268800130A, SAT VLT40DF - ARD268800130C, SAT VLT40SF - ARD268800120A, SAT VLT40SF - ARD268800120C, SAT VLT60DF - ARD2SAT00170A, SAT VLT60DF - ARD2SAT00170C, SAT VLT60SF - ARD2SAT00180C, SAT VST40DF - ARDSAT209018A, SAT VST40DF - ARDSAT209019A, SAT VST40DF - ARDSAT209022A, SAT VST40DF - ARDSAT209023A, SAT VST40SF - ARDSAT209010A, SAT VST40SF - ARDSAT209011A, SAT VST40SF - ARDSAT209014A, SAT VST40SF - ARDSAT209015A, SAT VST60DF - ARDSAT209034A, SAT VST60DF - ARDSAT209035A, SAT VST60DF - ARDSAT209038A, SAT VST60DF - ARDSAT209039A, SAT VST60SF - ARDSAT209026A, SAT VST60SF - ARDSAT209027A, SAT VST60SF - ARDSAT209030A, SAT VST60SF - ARDSAT209031A, STANDOP 40DF SINGLE - ARDSTP229005A, STANDOP 40SF SINGLE - ARDSTP229000A, STANDOP 44DF DOUBLE - ARDSTP229007A, STANDOP 44SF DOUBLE - ARDSTP229002A, STANDOP 60DF SINGLE - ARDSTP229006A, STANDOP 60SF SINGLE - ARDSTP229001A, STANDOP 64DF DOUBLE - ARDSTP229008A, STANDOP 64SF DOUBLE - ARDS

  A potential for a light system to fall in the operating room.

• 2024-01-19Open, ClassifiedEquipment maintenance

  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,

  A potential for a light system to fall in the operating room.

• 2024-01-19Open, ClassifiedEquipment maintenance

  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

  A potential for a light system to fall in the operating room.

• 2024-01-19Open, ClassifiedEquipment maintenance

  Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BRAINLAB CAMERA - ARDEQT269001A, BRAINLAB CAMERA - ARDEQT269001C, BRAINLAB CAMERA - ARDEQT269004A, BRAINLAB CAMERA - ARDEQT269004C, BRAINLAB CAMERA - ARDEQT269005A, BRAINLAB CAMERA - ARDEQT269005C, EQTBRB SAT12 - ARDSAT269000A, EQTBRB SAT13 - ARDSAT269001A, EQTFHS010 11 - ARDEQT239014A, EQTFHS010 SAT12 - ARDSAT239005A, EQTFHS010 SAT13 - ARDSAT239006A, EQTFHS010 SAT16 - ARDSAT239023A, EQTMHD231 - ARDEQT239013A, EQTMHD231 11 - ARDEQT239016A, EQTMHD231 16 - ARDEQT239023A, EQTMHD231 SAT12 - ARDSAT239013A, EQTMHD231 SAT13 - ARDSAT239014A, EQTMHS013 08 - ARD2EQT00010A, EQTMHS013 11 - ARDEQT239007A, EQTMHS013 14 - ARDEQT239008A, EQTMHS013 16 - ARDEQT239009A, EQTMHS013 SAT12 - ARDSAT239007A, EQTMHS013 SAT13 - ARDSAT239008A, EQTMHS021 11 - ARDEQT239010A, EQTMHS021 14 - ARDEQT239011A, EQTMHS021 16 - ARDEQT239012A, EQTMHS021 SAT12 - ARDSAT239009A, EQTMHS021 SAT13 - ARDSAT239010A, EQTSC07 SAT12 - ARD515031140A, EQTSC07 SAT13 - ARD515032140A, EQTSC07 SAT16 - ARD2SAT00120A, EQTSC07 SAT16 - ARDSAT229007A, EQTSHD 11 - ARDEQT229001A, EQTSHD SAT - ARD515031990A, EQTSHD SAT - ARD515032990A, EQTSPC12 08 - ARDEQT269008A, EQTSPC12 11 - ARDEQT269009A, EQTSPC12 SAT12 - ARDSAT269005A, EQTSPC12 SAT13 - ARDSAT269006A, EQTXHD127 08 - ARDEQT239026A, EQTXHD127 11 - ARDEQT239027A, EQTXHD127 16 - ARDEQT239028A, EQTXHD127 SAT12 - ARDSAT239021A, EQTXHD127 SAT13 - ARDSAT239022A, EQTXHS010 08 - ARD2EQT00030A, EQTXHS010 08 - ARDEQT239024A, EQTXHS010 10 - ARD2EQT00050A, EQTXHS010 11 - ARDEQT239017A, EQTXHS010 14 - ARDEQT239019A, EQTXHS010 16 - ARDEQT239020A, EQTXHS010 SAT12 - ARDSAT239015A, EQTXHS010 SAT13 - ARDSAT239018A, EQTXHS021 08 - ARDEQT239025A, EQTXHS021 11 - ARDEQT239018A, EQTXHS021 14 - ARDEQT239021A, EQTXHS021 16 - ARDEQT239022A, EQTXHS021 SAT12 - ARDSAT239019A, EQTXHS021 SAT13 - ARDSAT239020A, EQTXS3216 11 - ARDEQT239015A, EQTXS3216 SAT12 - ARDSAT239016A, EQTXS3216 SAT13 - ARDSAT239017A, HOR 14 XD2 - ARDEQT239006A, HOR 14 XD2 - ARDEQT239006C, HOR 14 XO - ARDEQT269002A, HOR 14 XO - ARDEQT269002C, HOR 14 XS0 - ARDEQT239004A, HOR 14 XS0 - ARDEQT239004C, HOR 14 XS1 - ARDEQT239005A, HOR 14 XS1 - ARDEQT239005C, HOR 16 XD2 - ARDEQT239003A, HOR 16 XD2 - ARDEQT239003C, HOR 16 XO - ARD267900080A, HOR 16 XO - ARDEQT269003A, HOR 16 XO - ARDEQT269003C, HOR 16 XS0 - ARDEQT239001A, HOR 16 XS0 - ARDEQT239001C, HOR 16 XS1 - ARDEQT239002A, HOR 16 XS1 - ARDEQT239002C, SAT BRAINLAB 12 - ARD515070110A, SAT BRAINLAB 12 - ARD515070110C, SAT BRAINLAB 13 - ARD515071110A, SAT BRAINLAB 13 - ARD515071110C, SAT BRAINLAB CAMERA - ARDSAT269000C, SAT BRAINLAB CAMERA - ARDSAT269001C, SAT BRAINLAB CAMERA - ARDSAT269003A, SAT BRAINLAB CAMERA - ARDSAT269003C, SAT BRAINLAB CAMERA - ARDSAT269004A, SAT BRAINLAB CAMERA - ARDSAT269004C, SAT CAM 12 - ARD515031880A, SAT CAM 12 - ARD515031880C, SAT CAM 13 - ARD515032880A, SAT CAM 13 - ARD515032880C, SAT MEDIA - ARD2SAT00210A, SAT MEDIA - ARD2SAT00220A, SAT MHD214 - ARDSAT239011A, SAT MHD214 - ARDSAT239012A, SAT ORCHID - ARDSAT229000A, SAT ORCHID - ARDSAT229000C, SAT ORCHID - ARDSAT229001A, SAT ORCHID - ARDSAT229001C, SAT ORCHID - ARDSAT229003A, SAT ORCHID - ARDSAT229003C, SAT ORCHID - ARDSAT229004A, SAT ORCHID - ARDSAT229004C, SAT ORCHIDE 12 - ARD515031991A, SAT ORCHIDE 12 - ARD515031991C, SAT ORCHIDE 12 - ARDSAT229005A, SAT ORCHIDE 12 - ARDSAT229005C, SAT ORCHIDE 13 - ARD515032991A, SAT ORCHIDE 13 - ARD515032991C, SAT ORCHIDE 13 - ARDSAT229006A, SAT ORCHIDE 13 - ARDSAT229006C, SAT PERF 258S - ARD515053130A, SAT PERF 258S - ARD515053130C, SAT SC 071 - ARD515031140C, SAT SC 071 - ARD515032140C, SAT SC07 HOR - ARD2SAT00120C, SAT SHD 12 - ARD515031990C, SAT SHD 13 - ARD515032990C, SAT SHD HOR - ARD2SAT00150A, SAT SHD HOR - ARD2SAT00150C, SAT SSD 13 - ARD515032080A, SAT SUP CAM 12 - ARD515031730A, SAT SUP CAM 13 - ARD515032730A, SAT XD 241 - ARD515031660A, SAT XD 241 - ARD515031660C, SAT XD 241 - ARD515032660A, SAT X

  A potential for a light system to fall in the operating room.

• 2024-01-19Open, ClassifiedEquipment maintenance

  Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, OHDII FHD QL AIR03 E - ARD568803967, OHDII FHD QL AIR04 E/U - ARD568803968, OHDII FHD QL+ VP01 - ARD569204944, OHDII AIR03 QL FHD E - ARD568803951

  A potential for a light system to fall in the operating room.

• 2019-06-21TerminatedDevice Design

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

  Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection

• 2019-06-21TerminatedDevice Design

  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP

  Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection