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Recall Observatory FDA recall evidence

Device product

Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga 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-5450

Z-2269-2023

May 15, 2023

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 92383
Status
Ongoing
Classification
Class II
Quantity
144 units
Official record key
device-enforcement:Z-2269-2023

Official wording

Reason: 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

Code information: UDI-DI: 00815686020651 Lot Number: 04541200528 and below

Distribution pattern: Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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