Olympus recalls SPiN Drive cytology needles with EM sensor tracking issues that may cause navigation errors during bronchoscopy. Affected models include INS-0392 with lot numbers 04991210310 and below. No immediate action needed but check for coil break warnings.
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 cytology needles that may malfunction during bronchoscopy procedures due to electromagnetic sensor issues. This could cause delays in critical medical procedures if the system incorrectly reports a coil break.
The electromagnetic sensor tracking system may malfunction during bronchoscopy, causing the device to incorrectly report a coil break warning. This could lead to delays in critical medical procedures without causing immediate injury.
Healthcare professionals using these needles during endobronchial procedures are most at risk. Patients undergoing bronchoscopy with these instruments may experience procedural delays.
Check for the model number INS-0392 on the needle packaging. Lot numbers 04991210310 and below are affected. These needles are intended for use in clinical interventions with CT or endoscopy.
Look for a system message indicating a coil break warning during use. If present, stop the procedure immediately.
No immediate action is required. The recall only addresses potential procedural delays, not immediate injury risks.
Stop the procedure immediately and contact Olympus for further instructions.
Lot numbers 04991210310 and below are affected.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2266-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2266-2023 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.
