North Geelong, AU · 2 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DWJ | System, Thermal Regulating | Class II | Cardiovascular | 1 | 2024-02-21 |
| FRG | Wrap, Sterilization | Class II | General Hospital | 1 | 2022-03-14 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-01-07 | Class II | Terminated | Z-0987-2020 | Cocoon Convective Warming System, Product Code: CWS5000 (110V). | — | Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on t… |
| 2020-01-07 | Class II | Terminated | Z-0986-2020 | Cocoon Convective Warming System, Product Code: CWS4000 (110V). | — | Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on t… |