Sanford, FL, US · 3 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Class II | Radiology | 2 | 2025-01-06 |
| OWB | — | — | — | 1 | 2021-11-17 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-09-08 | Class II | Ongoing | Z-0160-2024 | Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085 | — | An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by th… |
| 2023-02-28 | Class II | Ongoing | Z-0156-2024 | Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085 | — | An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one… |