Olympus recalls Veran:SPiN Thoracic Navigation Systems due to electromagnetic compatibility issues that could cause interference with other medical devices. Affected models include SYS-4230, SYS-4000, and others. No remedy specified in recall notice.
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 several models of Veran:SPiN Thoracic Navigation Systems because they were manufactured without meeting electromagnetic compatibility (EMC) standards. This could potentially cause interference with other medical devices during surgery. The recall does not include a specific fix or return process.
The devices failed to meet electromagnetic compatibility (EMC) standards, meaning they could interfere with other medical equipment during surgery. This interference might disrupt critical functions of surgical tools or patient monitoring systems.
Medical professionals using the Veran:SPiN Thoracic Navigation Systems for surgical procedures are most at risk. Patients undergoing surgery with these systems may be affected if the equipment malfunctions.
Check for the following model numbers: SYS-4230, SYS-4000, SYS-3230, SYS-3000, SYS-2400, SYS-2230, SYS-2000, SYS-1500, SYS-1000, SYS-0220, SYS-0185, SYS-0128, SYS-0002, or INS-7150. All serial numbers and lot numbers are also affected.
Identify your Veran:SPiN Thoracic Navigation System model by checking the device label or documentation.
The Veran:SPiN Thoracic Navigation Systems were manufactured without meeting electromagnetic compatibility (EMC) standards, which could cause interference with other medical devices during surgery.
Affected models include SYS-4230, SYS-4000, SYS-3230, SYS-3000, SYS-2400, SYS-2230, SYS-2000, SYS-1500, SYS-1000, SYS-0220, SYS-0185, SYS-0128, SYS-0002, and INS-7150.
The recall notice does not specify a remedy or action for affected devices.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2659-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2659-2023 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.
