Olympus Corporation of the Americas: Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical st

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: 1908.2 units Lot/code info: UDI-DI: 00815686020637 Lot Number: 06332230201 and below

UPC codes

00815686020637, 06332230201

Source

Official record: FDA (Device enforcement) ↗

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