Olympus recalls SPiN Xtend 2.0mm OD, 21ga instruments for potential EM sensor tracking issues during endobronchial procedures, which may cause procedural delays. Affected units have specific model and lot numbers.
Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
Olympus is recalling SPiN Xtend 2.0mm OD, 21ga instruments used in endobronchial procedures due to electromagnetic sensor tracking malfunctions that could cause procedural delays. This affects medical devices used in clinical settings where CT or endoscopy is employed.
The electromagnetic sensor tracking system may malfunction during endobronchial procedures, causing the device to report a coil break warning. This could lead to procedural delays but does not pose a direct risk of injury.
Healthcare professionals using these instruments during endobronchial procedures are most at risk. Patients undergoing procedures with these instruments may experience delays.
Check for model number INS-5450 and lot numbers 04541200528 and below on the instrument packaging. These instruments are intended for clinical use with CT or endoscopy procedures.
Look for model number INS-5450 and lot numbers 04541200528 and below on the instrument packaging.
The electromagnetic sensor tracking system may malfunction during endobronchial procedures, causing the device to report a coil break warning and potentially leading to procedural delays.
Check the model number and lot number on the packaging. If it matches INS-5450 with lot numbers 04541200528 and below, contact Olympus for further instructions.
The recall states this could result in procedural delays but does not mention any risk of injury.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2269-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2269-2023 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.
