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FDAMay 15, 2023device

Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0392

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

0081568602061304991210310

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0392 — Recall Details · AllClear