FDA-Device2023-02-15Class II
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Olympus Corporation of the Americas
Hazard
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
Sold states
FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA
Affected count
13 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1103-2023Don't want to check this manually?
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