Olympus recalls SPiN Thoracic Navigation System Model SYS-4000D (UDI: 00815686020101) due to grainy images when used with certain bronchoscopes causing surgery delays. Affected units have specific serial numbers listed in the 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
Olympus is recalling SPiN Thoracic Navigation System Model SYS-4000D because an incorrect DVI cable can cause grainy images during surgery, leading to longer procedures. This affects specific units with listed serial numbers and may delay critical medical procedures.
An incorrect DVI cable supplied with the SYS-4000D system can cause grainy images when used with certain bronchoscopes. This leads to additional troubleshooting time during surgery, potentially prolonging procedures without causing injury.
Healthcare professionals using the SPiN Thoracic Navigation System Model SYS-4000D with specific bronchoscope models (INS-7100 or INS-7130) are affected. The risk is low as the issue causes only procedural delays, not immediate harm.
Check if your SPiN Thoracic Navigation System has the model SYS-4000D and the listed serial numbers: 85330200430, 87896220519, 87899220524, 87379210921, 87835220505, 87832220502, 87767220420, 87777220415, 87827220427, 87736220412, 87891220517, 87864220509, 87738220412.
Verify your SPiN Thoracic Navigation System model is SYS-4000D with the listed serial numbers.
The recall occurs because an incorrect DVI cable can cause grainy images when used with specific bronchoscopes, leading to longer surgery times.
Units with the SYS-4000D model and serial numbers listed in the recall: 85330200430, 87896220519, 87899220524, 87379210921, 87835220505, 87832220502, 87767220420, 87777220415, 87827220427, 87736220412, 87891220517, 87864220509, 87738220412.
The recall does not specify a remedy, so affected users should contact Olympus for guidance on potential solutions.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1103-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1103-2023 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
