Olympus recalls Quest Spectrum 3 Fluorescent Imaging Systems (models ART-SYS-0029, ART-SYS-0030) due to electromagnetic interference that may cause device malfunction during procedures, potentially prolonging surgery or requiring additional medical intervention.
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
Olympus is recalling its Quest Spectrum 3 Fluorescent Imaging Systems (models ART-SYS-0029 and ART-SYS-0030) because they may malfunction due to electromagnetic interference during medical procedures. This could lead to longer surgeries or additional medical interventions.
The device may malfunction during procedures due to electromagnetic interference, which could cause the system to stop working. This might require restarting the procedure or additional medical steps, potentially prolonging surgery time and increasing patient risk.
Healthcare professionals using the Quest Spectrum 3 system for plastic and reconstructive surgeries in the U.S. are affected. Surgeons and medical staff working with these systems are most at risk.
Check for model numbers ART-SYS-0029 or ART-SYS-0030 on the device. These systems were distributed in the U.S. but not sold in the country.
Identify the model number on the device to confirm if it is ART-SYS-0029 or ART-SYS-0030.
Reach out to Olympus Corporation of the Americas for guidance on next steps.
The device may malfunction during procedures due to electromagnetic interference, which could lead to longer surgeries or additional medical interventions. It is not safe to use without addressing the issue.
Check for model numbers ART-SYS-0029 or ART-SYS-0030 on the device. These systems were distributed in the U.S. but not sold in the country.
Contact Olympus Corporation of the Americas for guidance on next steps. The recall does not specify a replacement or repair process.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0232-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0232-2025 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
