Light, Surgical, Accessories
General, Plastic Surgery · 21 CFR 878.4580
Recent MDR events
369 adverse event reports on file
- HARMONY IQJul 9, 2026MalfunctionBlack Diamond Video, Inc.3008776287-2026-00542
- HARMONY IQ INTEGRATION SYSTEMJun 17, 2026MalfunctionBlack Diamond Video, Inc.3008776287-2026-00529
- HEXAVUEJun 11, 2026MalfunctionBlack Diamond Video, Inc.3008776287-2026-00304
- HEXAVUEJun 1, 2026MalfunctionBlack Diamond Video, Inc.3008776287-2026-00157
- HEXAVUEJun 1, 2026MalfunctionBlack Diamond Video, Inc.3008776287-2026-00158
- ASPEN FLEXIBLE LIGHT HANDLE COVER; STERILEMay 29, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00055
- HV1000 INTEGRATION SYSTEMMay 15, 2026MalfunctionBlack Diamond Video, Inc.3008776287-2026-00149
- HEXAVUEMay 1, 2026MalfunctionBlack Diamond Video, Inc.3008776287-2026-00141
- STERIS STERILE LIGHTHANDLE COVERSMay 1, 2026MalfunctionSteris Corporation1043572-2026-00044
- HEXAVUEMay 1, 2026MalfunctionBlack Diamond Video, Inc.3008776287-2026-00142
Event type breakdown
Recalls
5 recall events for this product code
- Steris CorporationOpen, ClassifiedApr 28, 2023
Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers ar
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
Z-1475-2023 · View FDA record ↗ - Steris CorporationOpen, ClassifiedApr 28, 2023
Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
Z-1476-2023 · View FDA record ↗ - Sunnex Inc.TerminatedJul 24, 2007
Sunnex Celestial Star MR-16 (lamp holder) Medical Examination Lighting used in Model Numbers: CS2050C (ceiling mount), CS2050W (wall mount). CS2050D (dual mount
Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.
Z-1100-2007 · View FDA record ↗ - Sunnex Inc.TerminatedJul 24, 2007
Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS2015W (wall mount) , TS2015M (mobile) , TS2015W (wall mount) , TS2035M
Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.
Z-1101-2007 · View FDA record ↗ - Ecolab, Inc.TerminatedUnknown
Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly line
Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
Z-0523-2018 · View FDA record ↗
Registered firms
109 firms currently registered for this product code
Platinum Focus Group Ltd.
London London, City of, GB
S.i.m.e.o.n. Medical Usa, Llc
Greenville, SC, US
Guangdong Fuqiang Beauty Equipment Co.,limited
Qingyuan Guangdong, CN
Cbr Enterprise Limited
Hong Kong, HK
Black Diamond Video, Inc.
Richmond, CA, US
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Henso Medical (hangzhou) Co.,ltd.
Hangzhou Zhejiang, CN
Rongxing Plastic Jurong Co.,ltd.
Zhenjiang Jiangsu, CN
Joykey Industrial (pinghu) Limited
Pinghu City Zhejiang, CN
M.d. Japan, Ltd
Can Giuoc District Long An, VN
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Gcmedica Enterprise Ltd. (wuxi)
Wuxi Jiangsu, CN
Medline Industries, Lp - Northfield
Northfield, IL, US
Sterilization Services Of Virginia
RICHMOND, VA, US
Bioana
Monterrey Nuevo Leon, MX
Maquet S.a.s.
ARDON, ORLEANS CEDEX 2 Loiret, FR
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Alphatec Spine, Inc.
Carlsbad, CA, US
Avid Medical, Inc. A Medical Action Ind. Company 305
TOANO, VA, US
Videomed Srl
PORDENONE, IT
Teleflex Medical Llc
Morrisville, NC, US
Medical Action Industries, Inc. 306
ARDEN, NC, US
Videomed Srl
LIMENA Padova, IT
Suzhou Jingle Polymer Medical Apparatus Co., Ltd.
SUZHOU Jiangsu, CN
510(k) clearances
26 clearances for this product code
- Key Surgical, Inc.Sep 22, 2015
K150532 · Universal Light Handle Cover, Light Handle Cover
- Litex Manufacturing, Inc.Sep 29, 2014
K142386 · Operating Room Light Handle Adapter
- Microtek Medical, Inc. an Ecolab CompanyApr 8, 2014
K133554 · SURGICAL LIGHT HANDLE COVER
- Black Diamond VideoJan 7, 2014
K133413 · IDSS SLC
- Oasys HealthcareMar 1, 2012
K112133 · OASYS SURGICAL LIGHT CONTROLLER
- Image Stream Medical, Inc.Nov 23, 2010
K102791 · EASYSUITE SURGICAL LIGHT CONTROL (ESLC)
- Image Stream Medical, Inc.Jul 30, 2008
K081698 · MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)
- Xodus Medical, Inc.Jan 19, 2006
K053321 · LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER