Class 2 Device Recall Olympus HighFlow Insufflation Unit

• Date Initiated by Firm: September 25, 2023
• Date Posted: March 25, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1375-2024
• Recall Event ID: 94080
• 510(K)Number: K110294
• Product Classification: Insufflator, laparoscopic - Product Code HIF
• Product: Insufflation unit, UHI-4.
• Code Information: Model and serial number: UHI-4: UDI/DI: 04953170324147; All serial numbers.
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: Cynthia Ow; 647-999-3203
• Manufacturer Reason for Recall: 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".
• FDA Determined 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 connection with the overpressure issue, Olympus has identified software mitigations that will aid in the prevention of over pressurization situations. Olympus will be communicating with you at the end of summer 2024 regarding this software update for the UHI-4 device. If you decided to continue using the UHI-4, Olympus recommends a compatible insufflator be readily accessible as a backup during procedures. Action steps to be taken by the customer 1. Olympus will contact you based on device age and parts availability to schedule a repair to replace the CR board. Olympus will also be prioritizing this action for customers who have to continue using the UHI-4 during the quarantine action. To ensure continuity of care, Olympus will make every effort to provide a loaner while the unit is sent to the Olympus Service Center. 2. Please acknowledge receipt of this letter and, if applicable, indicate which serial numbers are still in use by your facility. 3. If you have further distributed this product, forward this letter to those facilities. Please contact your local Sales Representative for support regarding alternatives to the UHI-4 should you no longer wish to keep your UHI-4. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. If you have questions about this recall, p
• Quantity in Commerce: 3,172 Units
• Distribution: Domestic: Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HIF and Original Applicant = OLYMPUS MEDICAL SYSTEMS CORPORATION