GE Healthcare Finland Oy Recall 92455
Description: TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
GE Healthcare Finland Oy Recall 92455 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2027-2023 |
| Event ID | 92455 |
| Event Description | TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter |
| Product Type | Devices |
| Distribution | Worldwide |
| Quantity | 36337 devices |
| Recall Reason | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| Device Classification | 20230712 |
| Device Code Info | a) REF TS-AF-10, GTIN 0840682103176 b) REF TS-AF-25, GTIN 0840682103176 |
| Center Classification Date | 20230706 |
| Recall Initiation Date | 20230519 |
| Recalling Firm | GE Healthcare Finland Oy |
| Initial Notification | Letter |
| Similar To |