Device evidence

device-recall:cfres:210213

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.

Official recall number

Z-0232-2025

Evidence summary

Product code: OWN
Recall status: Open, Classified
Event initiated: September 24, 2024
Root cause: Component design/selection
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0232-2025