Olympus Corporation of the Americas: 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

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

Details from the source

Reason for recall: 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 Distribution: Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW. Quantity: 144 units Lot/code info: UDI-DI: 00815686020651 Lot Number: 04541200528 and below

UPC codes

00815686020651, 04541200528

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.