FDA Device recall Z-1103-2023
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
- FDA Device
- Class II
- ongoing
- Published 2023-02-15
On 2023-02-15 the FDA classified a Class II recall of SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D) by Olympus, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1103-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-13 |
| Published | 2023-02-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA |
Product
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
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
Identifiers
| code_info | UDI: 00815686020101 Serial Numbers: 85330200430, 87896220519, 87899220524, 87379210921, 87835220505, 87832220502, 87767…UDI: 00815686020101 Serial Numbers: 85330200430, 87896220519, 87899220524, 87379210921, 87835220505, 87832220502, 87767220420, 87777220415, 87827220427, 87736220412, 87891220517, 87864220509, 87738220412 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1103-2023%22
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