Home / Recalls / Olympus Corporation of the Americas / Z-0075-2024

Z-0075-2024 Class I Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
October 25, 2023
Initiation Date
September 22, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3136 units

Product Description

Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.

Reason for Recall

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.

Distribution Pattern

US Nationwide distribution.

Code Information

UDI-DI: 04953170324147; All Serial Numbers

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