PlainRecalls
FDA Devices Moderate Class II Ongoing

Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx" INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm INS-0304 Always-On Tip Tracked Guidewir

Reported: October 11, 2023 Initiated: August 10, 2023 #Z-2664-2023

Product Description

Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx" INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm INS-0050 vPad Patient Tracker, 5/Bx INS-0048 vPad Connector Cable

Reason for Recall

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

Details

Units Affected
60102 units
Distribution
Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx" INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm INS-0050 vPad Patient Tracker, 5/Bx INS-0048 vPad Connector Cable. Recalled by Olympus Corporation of the Americas. Units affected: 60102 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on October 11, 2023. Severity: Moderate. Recall number: Z-2664-2023.