Olympus recalls Veran endobronchial devices due to electromagnetic compatibility problems that could interfere with medical equipment. Affected models include specific needles, forceps, and guidewires with serial numbers starting with 0081568602.
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 endobronchial devices that may not work properly with medical equipment due to electromagnetic compatibility issues. This could cause interference with other medical devices during procedures.
The devices have manufacturing defects that don't meet design requirements and lack sufficient evidence of electromagnetic compatibility. This means they could interfere with other medical equipment during procedures, potentially causing malfunctions.
Healthcare professionals using Veran endobronchial devices for procedures like bronchoscopy are most at risk. Patients undergoing these procedures may also be affected if the devices interfere with critical medical equipment.
Check for Veran endobronchial devices with model numbers like INS-0392, INS-0382, or INS-0372. Look for serial numbers starting with 0081568602 or lot numbers listed in the recall notice.
Identify if your Veran device has a model number listed in the recall (e.g., INS-0392, INS-0382).
Check if your device has a serial number starting with 0081568602 or a listed lot number.
The recall includes Veran endobronchial devices with model numbers like INS-0392, INS-0382, and INS-0372, along with specific serial numbers starting with 0081568602.
The recall does not specify a stop-use instruction, so you do not need to stop using them immediately. However, you should check if your device is affected.
Check the model number and serial number on your device. Affected devices have model numbers listed in the recall and serial numbers starting with 0081568602.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2664-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2664-2023 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.
