Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
Reported: November 29, 2023 Initiated: September 25, 2023 #Z-0337-2024
Product Description
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
Details
- Recalling Firm
- Aizu Olympus Co., Ltd.
- Units Affected
- 16 units
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- Aizuwakamatsu, N/A
Frequently Asked Questions
What product was recalled? ▼
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.. Recalled by Aizu Olympus Co., Ltd.. Units affected: 16 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2023. Severity: Moderate. Recall number: Z-0337-2024.
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