Z-0232-2025Class II

Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest...

Name: Z-0232-2025 Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest...
Creator: Olympus Corporation of the Americas
Published: 2024-09-24
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-09-24 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of 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... on 2024-09-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0232-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-24
Posted: 2024-10-25
Recalling firm: OLYMPUS Corporation of the Americas
Product: 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.
Product code: OWN Confocal Optical Imaging
Reason for recall: 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
Root cause tag: design
FDA root cause: Component design/selection
Action: Olympus issued Urgent Medical Correction letter to Operating Room Director, Risk Management on 9/24/24. Letter states reason for recall, health risk and action to take: 1. Carefully read the content of this notification. 2. Quarantine and mark you Spectrum 3 unit appropriately to prevent usage. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification. 4. Acknowledge receipt of this letter through the Olympus recall portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number "0456 c. Complete the form as instructed. 5. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints or any associated injuries to the Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at [email protected].
Quantity in commerce: 3 units
Distribution: OH
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0232-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0232-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-25

Product code OWN

K143474Class IIArtemis Hand Held Imaging SystemQuest Medical Imaging / cleared 2015-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)