Richmond Heights, MO, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PQH | Iodinated Contrast Media Transfer Tubing Set | Class II | General Hospital | 1 | 2020-11-18 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-03-11 | Class II | Terminated | Z-1992-2021 | HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW) | — | Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate … |