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HIGH FLOW INSUFFLATION UNIT recallZ-1375-2024 · Olympus Corporation of the Americas · initiated Sep 25, 2023

Class II Open, Classified All recalls posted in March 2024

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Process control

What the company is doing

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

Recall details

Recall number
Z-1375-2024
Recall class
Class II
Status
Open, Classified
Initiated by the company
Sep 25, 2023
Posted by the FDA
Mar 25, 2024
Recalling firm
Olympus Corporation of the Americas
Quantity
3,172 Units
Product code
HIF
FDA submissions
K110294
Distribution
Domestic: Nationwide Distribution.

Product description

Insufflation unit, UHI-4.

Code information (models, lots, serial numbers)

Model and serial number: UHI-4: UDI/DI: 04953170324147; All serial numbers.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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