Reported Feb 15, 2023 · Ongoing
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- SPiN Thoracic Navigation System ModelSYS-4000 (SYS-4000D)
- Lot codes and dates
- UDI00815686020101
- Serial Numbers
85330200430878962205198789922052487379210921878352205058783222050287767220420877772204158782722042787736220412878912205178786422050987738220412
- Amount recalled
- 13 units
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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