Confocal Optical Imaging
FDA adverse event reports and recall history for confocal optical imaging (product code OWN), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,507
- Deaths
- 1
- Injuries
- 78
- Malfunctions
- 1,427
Reports per year
Source: FDA adverse event reports by year received, 2015–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-10-25Open, ClassifiedComponent design/selection
Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic and reconstructive surgeries.
Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to malfunction requiring the replacement of the device. This could potentially result in a prolonged procedure and/or require additional medical intervention
- 2022-11-23Open, ClassifiedUnder Investigation by firm
VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.
- 2022-11-23Open, ClassifiedUnder Investigation by firm
VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
XXX
- 2022-11-23Open, ClassifiedUnder Investigation by firm
VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.
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