Recall archive / FDA device enforcement
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D) — FDA record Z-1103-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 13, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Classification
- Class II
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 13 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1103-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: 00815686020101 Serial Numbers: 85330200430, 87896220519, 87899220524, 87379210921, 87835220505, 87832220502, 87767220420, 87777220415, 87827220427, 87736220412, 87891220517, 87864220509, 87738220412 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 15, 2023
- Recall initiation date
- Dec 13, 2022
- Center classification date
- Feb 7, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.