Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D) Recalled by Olympus Corporation of the Americas Due to A grainy image is observed when using a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.
Affected Products
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Quantity: 13 units
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed to 11 states: FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA
About Olympus Corporation of the Americas
Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report