Recall Z-1103-2023 ยท JAK System, X-Ray, Tomography, Computed
Olympus Corporation of the Americas
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
| Date | Feb 7, 2023 (initiated Dec 13, 2022) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | Olympus issued URGENT - Medical Device Field Corrective Action letter on 12/13/22. Letter states reason for recall, health risk and action to take: 1. Notify your users about this issue and stop using the single-use bronchoscopes (models INS-7100 or INS-7130) with SYS-4000 system until cable is replaced. Your users can continue to use the SYS-4000 using a reusable bronchoscope, with its respective video processor, without affecting their electromagnetic navigation (EMN) procedural experience. 2. Olympus requests that you acknowledge receipt of this letter by accessing the Olympus recall portal |
| Quantity | 13 units |
| Distribution | FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170023 | SPiN Thoracic Navigation System Veran Medical Technologies, Inc., May 15, 2017 |