Device, Medical Examination, Ac Powered
General Hospital · 21 CFR 880.6320
Recent MDR events
401 adverse event reports on file
- HEXALUXApr 22, 2026MalfunctionSteris Corporation1043572-2026-00038
- NEXUSApr 22, 2026MalfunctionSteris Corporation1043572-2026-00039
- LUCEA LED®Apr 9, 2026MalfunctionMaquet Sas9710055-2026-0000061
- HEXALUXDec 17, 2025MalfunctionSteris Corporation1043572-2025-00114
- HEXALUXOct 10, 2025MalfunctionSteris Corporation1043572-2025-00091
- HEXALUXOct 2, 2025MalfunctionSteris Corporation1043572-2025-00089
- HEXALUXAug 26, 2025MalfunctionSteris Corporation1043572-2025-00080
- HEXALUXJul 9, 2025MalfunctionSteris Corporation1043572-2025-00062
- WALL TRANSFORMERApr 15, 2025MalfunctionWelch Allyn Inc1316463-2025-00041
- EXAM LT IV LED W/TABLE/WALL MOUNT DOMMar 11, 2025MalfunctionWelch Allyn Inc1316463-2025-00024
Event type breakdown
Recalls
5 recall events for this product code
- MRIMed Inc.Open, ClassifiedFeb 20, 2026
MRI LED Mobile Exam Light Battery REF SL-111
Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
Z-1436-2026 · View FDA record ↗ - Stryker CommunicationsTerminatedAug 21, 2013
Stryker Visum 300 Ceiling-mounted Exam Light.
Potential incomplete final weld on the drop tube flange.
Z-1992-2013 · View FDA record ↗ - Burton Medical Products CorpTerminatedJul 20, 2004
All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after Aug
Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.
Z-0589-04 · View FDA record ↗ - Ohmeda MedicalTerminatedUnknown
Giraffe Exam Light
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.
Z-1501-2017 · View FDA record ↗ - Stryker CommunicationsTerminatedUnknown
Berchtold Chromophare F300 Exam Light
The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be insufficient mount force that may cause the equipment to fall, resulting in serious injury.
Z-2248-2017 · View FDA record ↗
Registered firms
92 firms currently registered for this product code
United Surgical Industries
SAHIBABAD Uttar Pradesh, IN
Derungs Licht Ag
Gossau Sankt Gallen, CH
Alltion (guangxi) Instrument Co., Ltd.
Wuzhou City Guangxi, CN
Hill-rom Company, Inc.
Ladson, SC, US
Globalmed Holdings, Llc
Scottsdale, AZ, US
Dkk Dai-ichi Shomei Co, Ltd
ITABASHI-KU Tokyo, JP
Eclipse Prism Medical Devices Pvt. Ltd
RABALE, NAVI MUMBAI Maharashtra, IN
Heine Optotechnik Gmbh & Co. Kg.
GILCHING Bavaria, DE
Medi.plan Gmbh & Co. Kg
Dortmund North Rhine-Westphalia, DE
Bear Down Brands, Llc
Fullerton, CA, US
Schneider Asr B.v.
Rotterdam-Albrandswaard Zuid-Holland, NL
Skytron, Llc
Grand Rapids, MI, US
Medical Illumination International, Inc
Chatsworth, CA, US
Getinge Ab
POZNAN Wielkopolskie, PL
Philips Electronics Ltd
Mississauga Ontario, CA
Narang Medical, Ltd.
New Delhi, IN
Purebrand Slutions Ltd
London England, GB
Mattes Instrumente Gmbh
Tuttlingen-Nendingen Baden-Wurttemberg, DE
Burton Medical Llc
Addison, IL, US
Dr. Mach Gmbh & Co. Kg
Grafing Bavaria, DE
Paras Surgico Factory
Delhi, IN
Rudolf Riester Gmbh
JUNGINGEN Baden-Wurttemberg, DE
Jedmed Instrument Company
Saint Louis, MO, US
Draegerwerk Ag & Co. Kgaa
LUEBECK Schleswig-Holstein, DE
Endonest Medical Systems Llp
PALGHAR Maharashtra, IN
510(k) clearances
37 clearances for this product code
- Nizar A. MullaniMar 27, 1996
K954943 · NEVOSCOPE
- Welch Allyn, Inc.Sep 22, 1995
K952835 · WELCH ALLYN VIDEO EPISCOPE
- Rudolf Riester GmbH & Co. KGDec 9, 1994
K945507 · H 5100, H 5200, H 5300
- The Lighthouse For the Blind, Inc.Aug 3, 1994
K941869 · SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG
- Burton Medical Products Corp.Apr 26, 1994
K936088 · WAVE FLUORESCENT MAGNIFIER
- Meddev International Corp.Feb 28, 1994
K940284 · MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION
- Skytron, Div. the Kmw Group, Inc.Feb 10, 1994
K933564 · SKYTRON EXAM LIGHT
- Berchtold Holding GmbHFeb 3, 1994
K935832 · CHROMOPHARE