Baar, CH · 3 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | Class II | Cardiovascular | 1 | 2026-08-14 |
| MHX | — | — | — | 1 | 2023-07-06 |
| DPS | Electrocardiograph | Class II | Cardiovascular | 1 | 2020-03-02 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-08-08 | Class II | Ongoing | Z-2672-2025 | Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006 | — | Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in … |
| 2024-07-24 | Class II | Ongoing | Z-2734-2024 | CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570 | — | Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs. |