Recall Z-1375-2024 ยท HIF Insufflator, Laparoscopic
Olympus Corporation of the Americas
Insufflation unit, UHI-4.
| Date | Mar 25, 2024 (initiated Sep 25, 2023) |
| Status | Open, Classified |
| Reason | Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off". |
| Root cause | Process control |
| Action | On February 16, 2024, the firm notified customers of the issue via URGENT MEDICAL DEVICE CORRECTIVE ACTION letters. Customers were informed of a new action regarding the UHI-4 front LED control panel. These units should have been quarantined from a previous October 25, 2023 notification related to an overpressure issue. Olympus will replace the CR board for UHI-4 older than 4.5 years. This repair of the CR board will not correct or address the overpressure issue which was the reason for the quarantine noted in our October 25, 2023, communication regarding the overpressure situation. In connect |
| Quantity | 3,172 Units |
| Distribution | Domestic: Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110294 | HIGH FLOW INSUFFLATION UNIT UHI-4 Olympus Medical Systems Corporation, Nov 18, 2011 |