Camera, Surgical And Accessories
General, Plastic Surgery · 21 CFR 878.4160
Recent MDR events
672 adverse event reports on file
- HexaVueJul 31, 2026MalfunctionBlack Diamond Video, Inc.3008776287-2026-00564
- HexaVueJul 31, 2026MalfunctionBlack Diamond Video, Inc.3008776287-2026-00565
- HexaVueJul 30, 2026MalfunctionBlack Diamond Video, Inc.3008776287-2026-00560
- HexaVueJul 30, 2026MalfunctionBlack Diamond Video, Inc.3008776287-2026-00561
- HexaVueJul 30, 2026InjuryBlack Diamond Video, Inc.3008776287-2026-00562
- HexaVueJul 30, 2026InjuryBlack Diamond Video, Inc.3008776287-2026-00563
- NAJul 29, 2026InjuryBlack Diamond Video, Inc.3008776287-2026-00559
- Vividimage 4KJul 27, 2026MalfunctionBlack Diamond Video, Inc.3008776287-2026-00483
- HexaVueJul 27, 2026InjuryBlack Diamond Video, Inc.3008776287-2026-00549
- HexaVueJul 27, 2026InjuryBlack Diamond Video, Inc.3008776287-2026-00550
Event type breakdown
Recalls
14 recall events for this product code
- Steris CorporationOpen, ClassifiedFeb 12, 2026
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
Z-1361-2026 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedJul 5, 2024
VidiaPort carrying arm, mount for auxiliary products, model numbers:
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
Z-2313-2024 · View FDA record ↗ - Barco N.V.Open, ClassifiedFeb 2, 2024
Barco MDSC-8527 NXF, Part Number K9352421
Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx NXF products. The functionality of the built-in MNA decoder is blocked.
Z-0979-2024 · View FDA record ↗ - Barco Inc.TerminatedNov 5, 2015
Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)
User settings were no longer on the monitor's memory after these systems were powered off and back on.
Z-0227-2016 · View FDA record ↗ - Sony Latin AmericaTerminatedApr 23, 2015
Sony Medical Monitor LMD-1951MD 19 inch
Monitor has either not turned on or has lost image during clinical use.
Z-1514-2015 · View FDA record ↗ - Linvatec Corp. dba ConMed LinvatecTerminatedMay 20, 2013
Ref: VP1600 HD Still Capture System ConMed Linvatec .
The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue.
Z-1340-2013 · View FDA record ↗ - Mako Surgical CorporationTerminatedMay 20, 2011
MAKO PN 204588 Camera
MAKO Surgical Corporation recalled ONE infra-red camera MAKO PN 204854 which was a component of their RIO Robotic Arm Interactive Orthopedic System with SSN P7-03127, on November 22, 2010. This component can function improperly and cause the accuracy of the system to be outside of the specification listed by the manufacturer. The recall was initiated after the camera manufacture, NDI, Waterloo, On
Z-2232-2011 · View FDA record ↗ - Linvatec Corp. dba ConMed LinvatecTerminatedApr 5, 2011
***REF VP6528***Qty 1***Articulating Arm, Secondary Flat Panel***RX Only***See Instructions for Use***CONMED LINVATEC, CONMED LINVATEC, 11311 CONCEPT BLVD, LARG
If the VHM Arm is left in the locked position, the gas spring can lose pressure and releasing the lock can result in a sudden downward movement.
Z-1893-2011 · View FDA record ↗ - Linvatec Corp. dba ConMed LinvatecTerminatedJan 4, 2011
The Power Cord Reel is labeled as follows:
ConMed Linvatec, Endoscopy Division, dba. ConMed Linvatec, Largo, Florida is recalling five products: (1.) Video Cart Premium 120 VAC (VP6501), (2.) Video Cart Multi-Specialty 120 VAC (VP6502), (3.) Video Cart Articulating Arm 120V (VP6504), (4.) Video Cart (VP8500), and (5.) Power Cord Assembly Self Retracting (VP6547). These products are being recalled due to there is a possibility that the Vid
Z-0847-2011 · View FDA record ↗ - Linvatec Corp. dba ConMed LinvatecTerminatedJan 4, 2011
Video Cart, Premium 120V product labeling is as follows:
ConMed Linvatec, Endoscopy Division, dba. ConMed Linvatec, Largo, Florida is recalling five products: (1.) Video Cart Premium 120 VAC (VP6501), (2.) Video Cart Multi-Specialty 120 VAC (VP6502), (3.) Video Cart Articulating Arm 120V (VP6504), (4.) Video Cart (VP8500), and (5.) Power Cord Assembly Self Retracting (VP6547). These products are being recalled due to there is a possibility that the Vid
Z-0848-2011 · View FDA record ↗
Registered firms
220 firms currently registered for this product code
Karl Storz Endoscopy Canada Ltd.
Mississauga Ontario, CA
Medline Industries, Lp - Northfield
Northfield, IL, US
Br Surgical Llc
Jacksonville, FL, US
Steris Corporation
MONTGOMERY, AL, US
Glycocheck Us, Llc
Alpine, UT, US
Arthrex Logistic Center Canada
London Ontario, CA
Tecnocirurgica Comercio De Materiais Medicos Cirurgicos E Hospitalares Ltda
Rio Claro Sao Paulo, BR
Designs For Vision, Inc.
Bohemia, NY, US
Enercon Technologies
GRAY, ME, US
Oasys Healthcare Corporation
Uxbridge Ontario, CA
Barco (suzhou) Healthcare Technology Co., Ltd.
Suzhou Jiangsu, CN
Zhengzhou Huaer Electro-optics Technology Co., Ltd.
Zhengzhou Henan, CN
Arthrex, Inc.
Ave Maria, FL, US
Carestream Dental Technology Topco Limited
London London, City of, GB
Boston Scientific Corporation
Marlborough, MA, US
Synergy Health Ast, Srl
Alajuela, CR
Rein Medical Gmbh
Moenchengladbach North Rhine-Westphalia, DE
Nds Surgical Imaging, Llc
Ludwigsstadt Bavaria, DE
Berchtold Gmbh & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Boston Scientific Limited
GALWAY, IE
Fsn Medical Korea Inc.
GUMI-SI Gyeongbuk, KR
Boston Scientific Limited
CLONMEL Tipperary, IE
Qisda Electronics (suzhou) Co., Ltd.
Suzhou Jiangsu, CN
Sterigenics U.s., Llc
Atlanta, GA, US
Shanghai Seegen Photoelectric Technology Co., Ltd
Shanghai, CN
510(k) clearances
18 clearances for this product code
- Jedmed Instrument Co.Jan 24, 1990
K900160 · ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER
- Sony Corp. of AmericaMar 14, 1989
K890826 · SONY VIDEO GRAPHIC PRINTER UP-850
- Sony Medical Electronics Co.Dec 22, 1988
K885042 · SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MD
- Sony Medical Electronics Co.Aug 4, 1988
K882958 · SONY VIDEO PRINTERS, UP SERIES
- M.P. Video, Inc.Jul 26, 1988
K882924 · MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS
- Technology For Imaging, Inc.Nov 2, 1987
K873419 · VIDEO PRINTER SYSTEM
- M.P. Video, Inc.May 7, 1987
K871595 · SURGICAL CAMERA ACCESSORIES
- Technology For Imaging, Inc.Oct 14, 1986
K863800 · ENDOSCOPIC VIDEO CAMERA