Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016" Stylet, 1235 mm L, 10/Bx INS-5410 SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx INS-5323 Sliding stopper INS-5300 "Always-On Tip Tracked¿ Triple Needle Brush, 12mm L, 1.8mm OD, 5/Bx"

Reason: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment

Code information: Model-UDI: INS-5500 View Optical Probe 00815686020729; INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx 00815686020651; INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC 00815686020644; INS-5411 0.016" Stylet, 1235 mm L, 10/Bx 00815686021191; INS-5410 SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx 00815686020637; INS-5323 Sliding stopper 00815686020712; INS-5300 "Always-On Tip Tracked¿ Triple Needle Brush, 12mm L, 1.8mm OD, 5/Bx" 00815686021207 . All serial numbers and all lot numbers

Distribution pattern: Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.