Olympus recalls Veran Percutaneous Models due to electromagnetic compatibility issues that could cause interference with other devices. Affected items include specific needle guide kits and localization needles with serial numbers listed.
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 certain Veran Percutaneous Models because they may not work properly with other electronic devices due to electromagnetic compatibility problems. This could lead to interference in medical equipment during procedures.
The Veran devices may not function correctly with other electronic equipment due to electromagnetic compatibility issues. This could cause interference in medical settings, potentially affecting the accuracy of procedures or safety of patients.
Medical professionals using the Veran Percutaneous Models for procedures are likely affected. Patients and staff using these devices in hospitals or clinics may be at risk if the equipment interferes with other medical devices.
Check for the specific model numbers: INS-5620, INS-5611, INS-5610, or INS-5600. All items with the listed serial numbers and lot numbers are affected.
Review the serial numbers and lot numbers provided in the recall notice to confirm if your device is affected.
The affected models include INS-5620 SPiN Perc Biopsy Needle Guide Kit, INS-5611 SPiN Perc Localization Needle, INS-5610 SPiN Perc Localization Needle, and INS-5600 SPiN Perc Biopsy Needle Guide Kit.
The recall does not require immediate discontinuation; however, you should check the serial numbers to confirm if your device is affected.
Check the serial numbers and lot numbers listed in the recall notice, which include specific model numbers and unique identifiers.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2661-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2661-2023 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.
