Olympus Corporation of the Americas Recall 92932
Description: Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Olympus Corporation of the Americas Recall 92932 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0075-2024 |
| Event ID | 92932 |
| Event Description | Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 3136 units |
| Recall Reason | There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures. |
| Device Classification | 20231025 |
| Device Code Info | UDI-DI: 04953170324147; All Serial Numbers |
| Center Classification Date | 20231018 |
| Recall Initiation Date | 20230922 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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