SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
FDA Recall #Z-1103-2023 — Class II — December 13, 2022
Product Description
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Reason for Recall
A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troubleshoot the device
Recalling Firm
Olympus Corporation of the Americas — Center Valley, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
13 units
Distribution
FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA
Code Information
UDI: 00815686020101 Serial Numbers: 85330200430, 87896220519, 87899220524, 87379210921, 87835220505, 87832220502, 87767220420, 87777220415, 87827220427, 87736220412, 87891220517, 87864220509, 87738220412
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated