Olympus recalls Veran Endobronchial catheters due to manufacturing defects affecting electromagnetic compatibility. These devices may cause interference with other electronic equipment. Affected models include specific SPiN Access Catheters and Biopsy Guide Kits 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 catheters because they were manufactured with defects that could cause electromagnetic interference. This means the devices might not work properly with other electronic equipment, potentially leading to safety issues during medical procedures.
The catheters were manufactured without meeting design requirements for electromagnetic compatibility. This means they might cause interference with other electronic devices, such as medical equipment, during procedures. However, the risk is not described as causing serious injury in normal use.
Healthcare professionals using the Veran catheters for bronchoscopy procedures are most at risk. Patients undergoing these procedures with the affected devices could experience interference with medical equipment.
Check for the model numbers: INS-5925, INS-5920, INS-5915, INS-5910, INS-5905, or INS-5900. The serial numbers start with 0081568602. These catheters are sold with Pentax or Olympus scopes.
Identify the model number on the catheter (e.g., INS-5925 SPiN Access Catheter 180 Degree).
Check the serial number on the device, which starts with 0081568602.
Olympus is recalling these catheters because they were manufactured with defects that affect electromagnetic compatibility, meaning they might cause interference with other electronic devices.
The recall states there is a risk of electromagnetic interference, but it does not indicate a risk of serious injury in normal use. The danger level is low risk.
Affected catheters have model numbers like INS-5925 or INS-5920 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-2660-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2660-2023 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.
