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Recall Observatory FDA recall evidence

Device product

Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.

Z-0336-2024

September 25, 2023

Class II

Product summary

Firm
Aizu Olympus Co., Ltd.
Event
Event 93222
Status
Ongoing
Classification
Class II
Quantity
27 units
Official record key
device-enforcement:Z-0336-2024

Official wording

Reason: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

Code information: Model Number (UDI-DI): HYF-V (04953170340185).

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    contamination that could lead