Olympus recalls SPiN Drive brush instruments for possible navigation errors during bronchoscopy procedures due to electromagnetic sensor tracking issues. Affected models include INS-0352 with specific 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 Drive brush instruments used in bronchoscopy procedures because electromagnetic sensor tracking may malfunction, causing navigation errors and potential procedural delays. This could affect patients undergoing endobronchial procedures.
The electromagnetic sensor tracking in these instruments can malfunction during endobronchial procedures, leading to navigation errors. This may cause the system to report a coil break warning, potentially delaying the procedure without causing immediate injury.
Healthcare professionals using these instruments during bronchoscopy procedures are most at risk. Patients undergoing endobronchial procedures may experience delays if the instrument malfunctions.
Check for the model number INS-0352 on the instrument. Lot numbers 04865230201 and below are affected. These instruments are intended for clinical use in bronchoscopy procedures.
Look for the model number INS-0352 on the instrument.
Confirm the lot number is 04865230201 or below.
The electromagnetic sensor tracking may malfunction during endobronchial procedures, causing navigation errors and potential procedural delays.
The affected model is INS-0352 with lot numbers 04865230201 and below.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2262-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2262-2023 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.