Olympus recalls Veran surgical tracking devices due to manufacturing defects affecting electromagnetic compatibility. Affected models include INS-5040, INS-5039, and other needle models with specific serial numbers.
Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
Olympus is recalling specific Veran surgical tracking devices because they were made with manufacturing defects that could cause electromagnetic interference. This means the devices might not work properly with other medical equipment, potentially leading to safety risks during surgery.
The Veran devices have manufacturing defects that don't meet design requirements and lack sufficient evidence of electromagnetic compatibility. This means the devices might interfere with other medical equipment, causing malfunctions during critical surgeries.
Surgical teams and hospitals that use Olympus Veran devices for tracking during procedures are most at risk. Patients and staff using the recalled models could face potential interference with other medical equipment.
Check for the model numbers INS-5040, INS-5039, INS-5036, INS-5034, INS-5032, INS-5029, INS-5028, INS-5024, INS-5023, INS-5017, or INS-5016. The devices also have specific serial numbers and lot numbers listed in the recall notice.
Identify if your Veran device matches the listed model numbers (e.g., INS-5040, INS-5039) or the specific needle models mentioned in the recall.
Reach out to Olympus Corporation of the Americas for assistance with the recall process and to confirm if your device is affected.
The recall states that the devices have manufacturing defects that could cause electromagnetic interference, but the official notice does not specify if they are unsafe to use in normal conditions.
The recall does not provide a specific remedy, so contact Olympus Corporation of the Americas directly for guidance on next steps.
Check the model numbers listed in the recall (e.g., INS-5040, INS-5039) or the specific serial numbers and lot numbers provided in the notice.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2663-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2663-2023 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.
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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.
