FDA recall Z-0337-2024

Aizu Olympus Co., Ltd. · Class II · device

Product

Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.

Reason for recall

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

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-09-25
Report date
2023-11-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Aizuwakamatsu, N/A, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0337-2024