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.

Reason: 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

Code information: UDI-DI: 08719324487047 Lot Code: Model: ART-SYS-0029, Serial: ART-SYS-2022-F04, ART-SYS-2022-A06, ART-SYS-2022-F05; Model: ART-SYS-0030; No distribution in the USA

Distribution pattern: OH