Waltham, MA, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HQF | — | — | — | 1 | 2025-04-03 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-12-05 | Class II | Ongoing | Z-1008-2026 | BVI Leos Laser and Endoscopy System. Model Number: OME6000U. | — | Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not insta… |