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Olympus Corporation of the Americas recalls Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interv
Recalled August 9, 2023 · FDA recall Z-2262-2023 · Olympus Corporation of the Americas
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 · FDA Class II
Units
1816.2 units
Sold at
Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW.
Description
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
Product
Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing Model: INS-0352
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →